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1.  Prevalence and Correlates of Fatigue in CKD and ESRD: Are Sleep Disorders a Key to Understanding Fatigue? 
American journal of nephrology  2013;38(6):489-495.
Fatigue is an important symptom to patients with advanced CKD. The aim of this study is to examine the prevalence and severity of fatigue among non-dialysis dependent CKD and ESRD patients; examine association of fatigue with subjective and objective sleep quality; identify other modifiable factors associated with fatigue.
Cross-sectional survey of 87 non-dialysis dependent CKD (eGFR ≤45 ml/min/1.73 m2) and 86 ESRD patients was done using Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) and SF-36 vitality scale. Higher FACIT-F score denoted less fatigue. Objective sleep was assessed using in-home polysomnography. Predictors of fatigue were determined using linear regression model.
Mean FACIT-F score among all participants was 34.5±11.0. Mean scores were similar among CKD and ESRD groups (34.25±11.28 versus 34.73±10.86; p=0.73). On univariate analyses, patients with higher levels of fatigue were more likely to have cardiovascular disease, benzodiazepine use, depressive symptoms, slightly lower hemoglobin and serum albumin levels. There was no significant association between severity of sleep apnea and level of fatigue (Apnea Hypopnea Index 20.1±27.6 versus 20.3±22.0; p=0.69). Presence of cardiovascular disease, low serum albumin, depressive symptoms, poor subjective sleep quality, excessive daytime sleepiness and restless legs syndrome (RLS) were independently associated with greater fatigue in multivariable regression models. The FACIT-F score correlated closely with the SF-36 vitality score (r =0.81, p<0.0001).
Patients with advanced CKD and ESRD experience profound fatigue. Depressive symptoms, RLS, excessive daytime sleepiness, and low albumin levels may provide targets for interventions to improve fatigue in patients with advanced CKD.
PMCID: PMC3925636  PMID: 24335380
End stage renal disease (ESRD); fatigue; sleep; chronic kidney disease; FACIT-F scale
2.  Infrequent Dialysis: A New Paradigm for Hemodialysis Initiation 
Seminars in dialysis  2013;26(6):10.1111/sdi.12133.
Nearly a half-century ago, the thrice-weekly hemodialysis schedule was empirically established as a means to provide an adequate dialysis dose while also treating the greatest number of end-stage renal disease patients using limited resources. Landmark trials of hemodialysis adequacy have historically been anchored to thrice-weekly regimens, but a recent randomized controlled trial demonstrated that frequent hemodialysis (six times per week) confers cardiovascular and survival benefits. Based on these collective data and experience, clinical practice guidelines advise against a less than thrice-weekly treatment schedule in patients without residual renal function, yet provide limited guidance on the optimal treatment frequency when substantial native kidney function is present. Thus, during the transition from Stage 5 chronic kidney disease to end-stage renal disease, the current paradigm is to initiate hemodialysis on a “full dose” thrice-weekly regimen even among patients with substantial residual renal function. However, emerging data suggests that frequent hemodialysis accelerates residual renal function decline, and infrequent regimens may provide better preservation of native kidney function. Given the high mortality rates during the first 90 days of hemodialysis and the survival benefits of preserved native kidney function, initiation with twice-weekly treatment schedules (“infrequent hemodialysis”) with an incremental increase in frequency over time may provide an opportunity to optimize patient survival. This review outlines the clinical benefits of post-hemodialysis residual renal function, studies of twice-weekly treatment regimens, and the potential risks and benefits of infrequent hemodialysis.
PMCID: PMC3844666  PMID: 24016197
3.  Medicaid Bed-Hold Policies and Hospitalization of Long-Stay Nursing Home Residents 
Health services research  2013;48(5):1617-1633.
To evaluate the effect of Medicaid bed-hold policies on hospitalization of long-stay nursing home residents.
Data Sources
A nationwide random sample of long-stay nursing home residents with data elements from Medicare claims and enrollment files, the Minimum Data Set, the Online Survey Certification and Reporting System, and Area Resource File. The sample consisted of 22,200,089 person-quarters from 754,592 individuals who became long-stay residents in 17,149 nursing homes over the period beginning January 1, 2000 through December 31, 2005.
Study Design
Linear regression models using a pre/post design adjusted for resident, nursing home, market and state characteristics. Nursing home and year-quarter fixed effects were included to control for time-invariant facility influences and temporal trends associated with hospitalization of long-stay residents.
Principal Findings
Adoption of a Medicaid bed-hold policy was associated with an absolute increase of 0.493 percentage points (95% CI: 0.039 – 0.946) in hospitalizations of long-stay nursing home residents, representing a 3.883 percent relative increase over the baseline mean.
Medicaid bed-hold policies may increase the likelihood of hospitalization of long-stay nursing home residents and increase costs for the federal Medicare program.
PMCID: PMC3737418  PMID: 23521571
Medicaid; Medicare; bed-hold policies; hospitalization
4.  Does Reducing Length of Stay Increase Rehospitalization Among Medicare Fee-for-Service Beneficiaries Discharged to Skilled Nursing Facilities? 
Rehospitalizations are costly and pose risks for patients. Increased rates of rehospitalization have accompanied decreases in hospital length of stay, raising the possibility that these two trends are causally related. Our objective was to analyze the relationship between length of stay and rehospitalization.
Retrospective cohort study.
6,537 hospitals nationwide from January 1999 through September 2005.
Medicare fee-for-service beneficiaries associated with 2,101,481 hospitalizations.
30-day rehospitalization derived from Medicare hospital claims using the implementation of Medicare’s post-acute care transfer policy as a quasi-experiment.
Medicare’s post-acute care transfer policy led to immediate declines in length of stay. When compared to a control group unaffected by the policy, one day decreases in length of stay were associated with absolute increases in 30-day rehospitalization of 1.56 percentage points (95% CI, 0.30 to 2.82) for acute myocardial infarction with major complications and 0.81 percentage points (95% CI, 0.03 to 1.60) for kidney or urinary tract infections without major complications. Patients hospitalized for acute myocardial infarction without major complications, heart failure, and kidney or urinary tract infections with major complications showed no increases in 30-day rehospitalization.
One day reductions in hospital length of stay are not consistently associated with increased rates of rehospitalization.
PMCID: PMC3773271  PMID: 23926902
Rehospitalization; length of stay; quality of care; Medicare; skilled nursing facilities
5.  Survival after Acute Hemodialysis in Pennsylvania, 2005–2007: A Retrospective Cohort Study 
PLoS ONE  2014;9(8):e105083.
Little is known about acute hemodialysis in the US. Here we describe predictors of receipt of acute hemodialysis in one state and estimate the marginal impact of acute hemodialysis on survival after accounting for confounding due to illness severity.
Materials and Methods
This is a retrospective cohort study of acute-care hospitalizations in Pennsylvania from October 2005 to December 2007 using data from the Pennsylvania Health Care Cost Containment Council. Exposure variable is acute hemodialysis; dependent variable is survival following acute hemodialysis. We used multivariable logistic regression to determine propensity to receive acute hemodialysis and then, for a Cox proportional hazards model, matched acute hemodialysis and non-acute hemodialysis patients 1∶5 on this propensity.
In 2,131,248 admissions of adults without end-stage renal disease, there were 6,657 instances of acute hemodialysis. In analyses adjusted for predicted probability of death upon admission plus other covariates and stratified on age, being male, black, and insured were independent predictors of receipt of acute hemodialysis. One-year post-admission mortality was 43% for those receiving acute hemodialysis, compared to 13% among those not receiving acute hemodialysis. After matching on propensity to receive acute hemodialysis and adjusting for predicted probability of death upon admission, patients who received acute hemodialysis had a higher risk of death than patients who did not over at least 1 year of follow-up (hazard ratio 1·82, 95% confidence interval 1·68–1·97).
In a populous US state, receipt of acute hemodialysis varied by age, sex, race, and insurance status even after adjustment for illness severity. In a comparison of patients with similar propensity to receive acute hemodialysis, those who did receive it were less likely to survive than those who did not. These findings raise questions about reasons for lack of benefit.
PMCID: PMC4139312  PMID: 25141028
6.  Primary care physicians’ familiarity, beliefs, and perceived barriers to practice guidelines in non-diabetic CKD: a survey study 
BMC Nephrology  2014;15:64.
Most non-dialysis dependent chronic kidney disease (CKD) patients are cared for by their primary care physicians (PCPs). Studies suggest many CKD patients receive suboptimal care. Recently, CKD clinical practice guidelines were updated with additional emphasis on albuminuria.
We performed an internet-based, cross-sectional survey of active PCPs in the United States using the American Medical Association Physician Masterfile. We explored CKD guideline familiarity, self-reported practice behaviors, and attitudinal and external barriers to implementing guideline recommendations, including albuminuria testing.
Of 12,034 PCPs targeted, 848 opened a study email, 165 (19.5%) responded. Most respondents (88%) spent ≥50% of their time in clinical care. Respondents were generally in private practice (46%). Most PCPs (96%) felt that eGFR values were helpful. Approximately, 75% and 91% of PCPs reported testing for albuminuria in non-diabetic hypertensive patients with an eGFR > 60 ml/min/1.73 m2 and < 60 ml/min/1.73 m2, respectively. Barriers to albuminuria testing included a lack of effect on management, limited time, and the perceived absence of guidelines recommending testing. While PCPs expressed high levels of agreement with the definition of CKD, 30% were concerned with overdiagnosis in older adults with an eGFR in the CKD stage 3a range. Most PCPs felt that angiotensin converting enzyme inhibitor (ACEi)/ angiotensin II receptor blockers (ARBs) improved outcomes in CKD, though agreement was lower with severe vs. moderate albuminuria (78% vs. 85%, respectively, p = 0.03). Many PCPs (51%) reported being unfamiliar with CKD guidelines, but were receptive to systematic interventions to improve their CKD care.
PCPs generally agree with CKD clinical practice guidelines regarding CKD definition and albuminuria testing. However, future interventions are necessary to improve PCPs’ familiarity with CKD guidelines, overcome barriers to albuminuria testing and, assist PCPs in targeting ACEi/ARBs to the patients most likely to benefit.
PMCID: PMC4021215  PMID: 24755164
Chronic kidney disease; Primary care physicians; Survey; Estimate glomerular filtration rate; Albuminuria; Angiotensin converting enzyme inhibitors; Angiotensin II receptor blockers; Barriers
8.  Ecological momentary assessment of fatigue, sleepiness, and exhaustion in ESKD 
BMC Nephrology  2014;15:29.
Many patients on maintenance dialysis experience significant sleepiness and fatigue. However, the influence of the hemodialysis (HD) day and circadian rhythms on patients’ symptoms have not been well characterized. We sought to use ecological momentary assessment to evaluate day-to-day and diurnal variability of fatigue, sleepiness, exhaustion and related symptoms in thrice-weekly maintenance HD patients.
Subjects used a modified cellular phone to access an interactive voice response system that administered the Daytime Insomnia Symptom Scale (DISS). The DISS assessed subjective vitality, mood, and alertness through 19 questions using 7- point Likert scales. Subjects completed the DISS 4 times daily for 7 consecutive days. Factor analysis was conducted and a mean composite score of fatigue-sleepiness-exhaustion was created. Linear mixed regression models (LMM) were used to examine the association of time of day, dialysis day and fatigue, sleepiness, and exhaustion composite scores.
The 55 participants completed 1,252 of 1,540 (81%) possible assessments over the 7 day period. Multiple symptoms related to mood (e.g., feeling sad, feeling tense), cognition (e.g., difficulty concentrating), and fatigue (e.g., exhaustion, feeling sleepy) demonstrated significant daily and diurnal variation, with higher overall symptom scores noted on hemodialysis days and later in the day. In factor analysis, 4 factors explained the majority of the observed variance for DISS symptoms. Fatigue, sleepiness, and exhaustion loaded onto the same factor and were highly intercorrelated. In LMM, mean composite fatigue-sleepiness-exhaustion scores were associated with dialysis day (coefficient and 95% confidence interval [CI] 0.21 [0.02 – 0.39]) and time of day (coefficient and 95% CI 0.33 [0.25 – 0.41]. Observed associations were minimally affected by adjustment for demographics and common confounders.
Maintenance HD patients experience fatigue-sleepiness-exhaustion symptoms that demonstrate significant daily and diurnal variation. The variability in symptoms may contribute to poor symptom awareness by providers and greater misclassification bias of fatigue related symptoms in clinical studies.
PMCID: PMC3927224  PMID: 24502751
End-stage renal disease; Alertness; Fatigue; Symptoms; Ecological momentary assessment
9.  Effect of More Frequent Hemodialysis on Cognitive Function in the Frequent Hemodialysis Network Trials 
Cognitive impairment is common among patients with end-stage renal disease receiving hemodialysis 3x-per-week.
Study Design
Randomized Clinical Trial
Setting & Participants
218 subjects participating in the Frequent Hemodialysis Network (FHN) Daily Trial and 81 subjects participating in the FHN Nocturnal Trial.
The Daily Trial tested in-center hemodialysis 6x-per-week versus 3x-per-week. The Nocturnal Trial tested home nocturnal hemodialysis 6x-per-week versus home or in-center hemodialysis 3x-per-week.
Cognitive function was measured at baseline, month four, and month 12. The primary outcome was performance on the Trail-Making Test, Form B, a measure of executive function, and a secondary outcome was performance on the Modified Mini-Mental State Examination, a measure of global cognition. The domains of attention, psychomotor speed, memory and verbal fluency were assessed in 59 participants in the Daily Trial and 19 participants in the Nocturnal Trial.
We found no benefit of frequent hemodialysis in either trial for the primary cognitive outcome (Daily Trial: OR for improvement, 0.99; 95% CI, 0.59–1.66; Nocturnal Trial: OR, 1.19; 95% CI, 0.48–2.96). Similarly, there was no benefit of frequent hemodialysis in either trial on global cognition, the secondary cognitive outcome. Exploratory analyses in the Daily Trial suggested possible benefits of frequent hemodialysis on memory and verbal fluency, but not on attention and psychomotor speed. Exploratory analyses in the Nocturnal Trial suggested no benefit of frequent hemodialysis on attention, psychomotor speed, memory, or verbal fluency.
Unblinded intervention, small sample
Frequent hemodialysis did not improve executive function or global cognition.
PMCID: PMC3546160  PMID: 23149295
dialysis; end-stage renal disease; cognitive function
10.  Antipsychotic Use Among Nursing Home Residents Admitted with Hip Fracture 
Journal of the American Geriatrics Society  2012;61(1):10.1111/jgs.12043.
Widespread use of antipsychotic medications among skilled nursing home (NH) residents for off-label indications has become a concern of clinicians and policy makers. The objective of this study was to evaluate the association between receiving antipsychotics and the outcomes of a cohort of NH patients with and without presumed delirium after hip fracture.
Population based cohort study.
11,119 nursing homes nationwide, from 01 January 2000 to 31 December 2007.
First-time NH admits with hip fracture (N=77,759).
The Nursing Home Confusion Assessment Method was utilized to identify residents with no delirium, subsyndromal delirium, and full delirium. Propensity score reweighting was used with analyses stratified by delirium level.
Among patients with no delirium symptoms, about 5 percent (n = 3,250) received antipsychotic drugs. These individuals were less likely to be discharged home (OR 0.68; P < 0.001), had a higher likelihood of death prior to nursing home discharge (OR 1.28; P = 0.03), stayed in nursing homes longer (β 2.83; P = 0.05), and had less functional improvement at discharge (β -0.47; P = 0.03). Receipt of antipsychotics among participants with mild delirium was associated with a lower likelihood of discharge home (OR 0.74; P = 0.03).
Among NH residents with hip fracture and no delirium symptoms, use of antipsychotics was associated with worse outcomes, with the exception of rehospitalization. No clear benefits were associated with antipsychotic use for those with presumed delirium.
PMCID: PMC3854869  PMID: 23252409
Skilled Nursing Facility; Delirium; Antipsychotics
11.  Association of Sleep Disordered Breathing With Cognitive Dysfunction in CKD Stages 4–5 
Sleep disordered breathing (SDB) and cognitive impairment are common among chronic kidney disease (CKD) patients. SDB is known to be a risk factor for cognitive dysfunction in the general population, but this association has not been studied in CKD patients.
Study Design
Cross-sectional study.
Settings & Participants
A cohort of 169 CKD stage 4–5 patients.
SDB; covariates included demographics, diabetes, cardiovascular disease, depression and dialysis modality.
Cognitive impairment, generally defined as a score 1.5 standard deviations or more from the age, education level adjusted normative cognitive test score.
Standardized health interview, neurocognitive assessment, sleep related questionnaires, and polysomnography.
SDB (apnea-hypopnea index > 15) was diagnosed in 83 (49.1%) subjects. This group had a significantly higher prevalence of nocturnal hypoxemia (65.8% vs. 26.8%, p<0.001) and excessive daytime sleepiness (38.6% vs. 20.7%, p=0.01). In addition, this group had significantly lower scores in tests measuring verbal memory, working memory, attention, and psychomotor speed. SDB was associated with a higher risk of immediate verbal memory impairment after adjustment for known confounders (adjusted OR, 2.67; 95% CI, 1.17–6.08). However, in a subgroup analysis of older adults (age>60), there were no significant differences in cognitive testing between the groups with and without sleep-disordered breathing.
Cross-sectional design, limited sample size.
SDB is associated with cognitive impairments, especially impaired verbal memory in advanced CKD patients. However, the impact appeared limited in older adults. Early evaluation and management of SDB in patients with CKD may provide an opportunity to improve cognitive function.
PMCID: PMC3549635  PMID: 23063144
Chronic kidney disease; cognitive impairment; sleep disordered breathing
12.  Anti-Inflammatory and Anti-Oxidative Nutrition in Hypoalbuminemic Dialysis Patients (AIONID) study: results of the pilot-feasibility, double-blind, randomized, placebo-controlled trial 
Low serum albumin is common and associated with protein-energy wasting, inflammation, and poor outcomes in maintenance hemodialysis (MHD) patients. We hypothesized that in-center (in dialysis clinic) provision of high-protein oral nutrition supplements (ONS) tailored for MHD patients combined with anti-oxidants and anti-inflammatory ingredients with or without an anti-inflammatory appetite stimulator (pentoxifylline, PTX) is well tolerated and can improve serum albumin concentration.
Between January 2008 and June 2010, 84 adult hypoalbuminemic (albumin <4.0 g/dL) MHD outpatients were double-blindly randomized to receive 16 weeks of interventions including ONS, PTX, ONS with PTX, or placebos. Nutritional and inflammatory markers were compared between the four groups.
Out of 84 subjects (mean ± SD; age, 59 ± 12 years; vintage, 34 ± 34 months), 32 % were Blacks, 54 % females, and 68 % diabetics. ONS, PTX, ONS plus PTX, and placebo were associated with an average change in serum albumin of +0.21 (P = 0.004), +0.14 (P = 0.008), +0.18 (P = 0.001), and +0.03 g/dL (P = 0.59), respectively. No related serious adverse events were observed. In a predetermined intention-to-treat regression analysis modeling post-trial serum albumin as a function of pre-trial albumin and the three different interventions (ref = placebo), only ONS without PTX was associated with a significant albumin rise (+0.17 ± 0.07 g/dL, P = 0.018).
In this pilot-feasibility, 2 × 2 factorial, placebo-controlled trial, daily intake of a CKD-specific high-protein ONS with anti-inflammatory and anti-oxidative ingredients for up to 16 weeks was well tolerated and associated with slight but significant increase in serum albumin levels. Larger long-term controlled trials to examine hard outcomes are indicated.
Electronic supplementary material
The online version of this article (doi:10.1007/s13539-013-0115-9) contains supplementary material.
PMCID: PMC3830006  PMID: 24052226
Albumin; Hypoalbuminemia; Inflammation; Protein intake; Hemodialysis; Oral nutrition supplements; Anti-oxidant ingredients; Anti-inflammatory ingredients
13.  Resistant Hypertension and Obstructive Sleep Apnea in the Setting of Kidney Disease 
Journal of hypertension  2012;30(5):960-966.
To explore the relationship between obstructive sleep apnea (OSA) and resistant hypertension in chronic kidney disease (CKD) and end-stage renal disease (ESRD).
We examined sleep parameters and blood pressure (BP) in 224 community-based, non-CKD participants from the Sleep-SCORE study, 88 non-dialysis dependent CKD and 95 ESRD participants. Unattended home polysomnography with standardized scoring protocols and automated BP monitors were used. Resistant hypertension was defined as a BP ≥ 140/90 mmHg despite ≥ 3 antihypertensives.
Mean systolic BP of the CKD and ESRD groups were significantly higher than the non-CKD group (148.2mmHg [23.8], 144.5mmHg [26.7] vs. 132.2mmHg [26.7], respectively; P<0.0001) despite the use of more anti-hypertensive medications. The CKD and ESRD groups had higher rates of resistant hypertension than the non-CKD group (41.4%, 22.6% vs. 6.7%, respectively; P<0.0001). The severity of sleep apnea was associated with a higher risk of resistant hypertension. While resistant hypertension was associated with severe sleep apnea in participants with ESRD (odds ratio [OR] 7.1, 95% confidence interval [CI] 2.2-23.2), there was no significant association in the non-CKD (OR 3.5, 95% CI 0.8-15.4) or CKD groups (OR 1.2, 95% CI 0.4-3.7) after accounting for case-mix.
The association between resistant hypertension and sleep apnea appeared robust in ESRD. OSA may contribute to resistant hypertension or both may be linked to a common underlying process such as volume excess. Future studies in patients with kidney disease should further characterize the resistant hypertension - OSA relationship and determine whether treatment of underlying mechanisms may improve outcomes.
PMCID: PMC3771863  PMID: 22388231
Sleep apnea; chronic kidney disease; end-stage renal disease; hypertension; resistant hypertension
14.  A National Survey of Independent Living Donor Advocates: The Need for Practice Guidelines 
In 2000, representatives of the transplant community convened for a meeting on living donation in an effort to provide recommendations to promote the welfare of living donors. One key recommendation included in the consensus statement was that all transplant centers which have performed living donor surgeries have an Independent Living Donor Advocate (ILDA) “whose only focus is on the best interest of the donor.” The aims of this study were to begin to understand the sociodemographic characteristics, selection and training, and clinical practices of ILDAs. All U.S. transplant centers performing living donor surgeries were contacted to identify the ILDA at their center. One hundred and twenty ILDAs (60%) completed an anonymous survey. Results indicated considerable variability with regard to the sociodemographic characteristics of ILDAs, how the ILDA was selected and trained, and the ILDAs’ clinical practices, particularly ethical challenges encountered by ILDAs. The variability observed may result in differential selection of donors and could have a potential negative impact the lives of both donors and transplant candidates. The variability in the background, training, and practice of ILDAs suggests the need for strategies, such as practice guidelines, to standardize the interaction between ILDAs and living donors.
PMCID: PMC3409345  PMID: 22548793
15.  Acute kidney injury 
Clinical Evidence  2011;2011:2001.
Acute renal failure is characterised by abrupt and sustained decline in glomerular filtration rate, which leads to accumulation of urea and other chemicals in the blood. The term acute kidney injury has been introduced to encompass a wide spectrum of acute alterations in kidney function from mild to severe. Acute kidney injury is classified according to the RIFLE criteria, in which a change from baseline serum creatinine or urine output determines the level of renal dysfunction.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to prevent acute kidney injury in people at high risk? What are the effects of treatments for critically ill people with acute kidney injury? We searched: Medline, Embase, The Cochrane Library, and other important databases up to December 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
We found 82 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
In this systematic review we present information relating to the effectiveness and safety of the following interventions: albumin supplementation plus loop diuretics (intravenous), aminoglycosides, aminophylline, amphotericin B, calcium channel blockers, contrast media, dialysis membranes, dopamine, early versus late dialysis, extended daily dialysis, fenoldopam, loop diuretics, mannitol, N-acetylcysteine, natriuretic peptides, renal replacement therapy, sodium bicarbonate-based fluids, sodium chloride-based fluids, and theophylline.
Key Points
Acute renal failure (also called acute kidney injury) is characterised by abrupt and sustained decline in GFR, which leads to accumulation of urea and other chemicals in the blood. It can be classified according to a change from baseline serum creatinine or urine output, with "Risk" being defined by either a 50% increase in serum creatinine, or a urine output of <0.5 mL/kg/hour for at least 6 hours; and "Failure" being defined by a three-fold increase in serum creatinine, or a urine output of <0.3 mL/kg/hour for 24 hours.
In people at high risk of developing acute renal failure, intravenous sodium chloride (0.9%) reduces incidences of acute renal failure compared with unrestricted oral fluids or 0.45% intravenous sodium chloride solution. N-acetylcysteine plus intravenous fluids may reduce contrast nephropathy compared with intravenous fluids alone in people undergoing contrast nephrography, although data about prevention of renal failure are inconclusive. Sodium bicarbonate may be as effective as sodium chloride but the evidence is conflicting so we cannot draw conclusions. Low-osmolality contrast medium is less nephrotoxic compared with high-osmolality media, and iso-osmolar contrast media has similar nephrotoxicity to low-osmolar contrast media. We found insufficient evidence on the effects of prophylactic renal replacement therapy. Single-dose aminoglycosides seem as beneficial as multiple doses for treating infections, but are less nephrotoxic. Lipid formulations of amphotericin B may cause less nephrotoxicity than standard formulations, although the evidence for this is somewhat sparse. Mannitol, theophylline, aminophylline, fenoldopam, and calcium channel blockers do not seem useful treatments for people at high risk of acute renal failure.
We don't know whether continuous renal replacement therapy is any more effective than intermittent renal replacement therapy. High-dose continuous renal replacement therapy was ineffective in treatment of people critically ill with acute kidney injury, and is also associated with an increased risk of hypophosphataemia, hypokalaemia, and hypotension. Synthetic dialysis membranes may be associated with improved survival compared with cellulose-based membranes for treating people with acute renal failure; however, evidence is inconclusive and of variable quality. Loop diuretics plus fluids seem to increase the risk of developing acute renal failure compared with fluids alone, both in high-risk and critically ill people, and do not seem to improve renal function or mortality compared with placebo in people with acute renal failure, but may increase the risks of ototoxicity and volume depletion.We found no evidence that examined whether intravenous albumin supplementation improved the effects of loop diuretics, or whether continuous infusion was any more effective than bolus injection in the treatment of people critically ill with acute renal failure.
Neither natriuretic peptides nor dopamine seem beneficial in either high-risk or critically ill people, and both are associated with significant adverse effects.
We don't know whether early versus late renal replacement therapy or extended daily dialysis improve outcomes in people critically ill with acute kidney injury.
PMCID: PMC3217737  PMID: 21443811
16.  Perceived Discrimination Predicts Longer Time to be Accepted for Kidney Transplant 
Transplantation  2012;93(4):423-429.
Although end-stage kidney disease (ESKD) in African Americans (AAs) is four times greater than in Whites, AAs are less than half as likely to undergo kidney transplantation (KT). This racial disparity has been found even after controlling for clinical factors such as co-morbid conditions, dialysis vintage and type, and availability of potential living donors. Therefore, studying non-medical factors is critical to understanding disparities in KT.
Design, Setting, and Participants
We conducted a longitudinal cohort study with 127 AA and White patients with ESKD undergoing evaluation for KT (12/06 – 7/07) to determine whether, after controlling for medical factors, differences in time to acceptance for transplant is explained by patients’ cultural factors (e.g., perceived racism and discrimination, medical mistrust, religious objections to living donor KT), psychosocial characteristics (e.g., social support, anxiety, depression), or transplant knowledge. Participants completed 2 telephone interviews (shortly after initiation of transplant evaluation and after being accepted or found ineligible for transplant).
Results indicated that AA patients reported higher levels of the cultural factors than did Whites. We found no differences in co-morbidity or availability of potential living donors. AAs took significantly longer to get accepted for transplant than did Whites (HR=1.49, p=0.005). After adjustment for demographic, psychosocial, and cultural factors, the association of race with longer time for listing was no longer significant.
We suggest that interventions to address racial disparities in KT incorporate key non-medical risk factors in patients.
PMCID: PMC3275654  PMID: 22228417
kidney transplantation; disparities; discrimination
17.  The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial 
Kidney international  2011;80(10):1080-1091.
Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments. To study this further, we randomized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week, all with single-use high-flux dialyzers. The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/Vurea, a 1.74-fold higher average number of treatments per week, and a 2.45-fold higher average weekly treatment time than the 42 patients in the conventional arm. We did not find a significant effect of nocturnal hemodialysis for either of the two coprimary outcomes (death or left ventricular mass (measured by MRI) with a hazard ratio of 0.68, or of death or RAND Physical Health Composite with a hazard ratio of 0.91). Possible explanations for the left ventricular mass result include limited sample size and patient characteristics. Secondary outcomes included cognitive performance, self-reported depression, laboratory markers of nutrition, mineral metabolism and anemia, blood pressure and rates of hospitalization, and vascular access interventions. Patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension, but no significant benefit among the other main secondary outcomes. There was a trend for increased vascular access events in the nocturnal arm. Thus, we were unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either coprimary outcome.
PMCID: PMC3569086  PMID: 21775973
hemodialysis; left ventricular mass; nocturnal hemodialysis; RAND physical health composite (PHC) SF-36; randomized clinical trial; vascular access
18.  Quality of Life and Psychosocial Factors in African Americans with Hypertensive Chronic Kidney Disease 
Health-related quality of life (HRQOL) is poorly understood in patients with chronic kidney disease (CKD) prior to end-stage renal disease. The association between psychosocial measures and HRQOL has not been fully explored in CKD, especially in African Americans. We performed a cross-sectional analysis of HRQOL and its association with sociodemographic and psychosocial factors in African Americans with hypertensive CKD.
There were 639 participants in the African American Study of Kidney Disease and Hypertension Cohort Study. The Short Form-36 was used to measure HRQOL. The Diener Satisfaction with Life Scale measured life satisfaction, the Beck Depression Inventory-II assessed depression, the Coping Skills Inventory-Short Form measured coping, and the Interpersonal Support Evaluation List-16 was used to measure social support.
Mean participant age was 60 years at enrollment, and 61% were male. Forty-two percent reported a household income below $15,000/year. Higher levels of social support, coping skills, and life satisfaction were associated with higher HRQOL, while unemployment and depression were associated with lower HRQOL (p<0.05). There was a significant positive association between higher estimated glomerular filtration rate (eGFR) with the Physical Health Composite (PHC) score (p=0.004) but not the Mental Health Composite (MHC) score (p=0.24).
Unemployment was associated with lower HRQOL, and lower eGFR was associated with lower PHC. African Americans with hypertensive CKD with better social support and coping skills had higher HRQOL. This study demonstrates an association between CKD and low HRQOL and highlights the need for longitudinal studies to further examine this association.
PMCID: PMC3240805  PMID: 22153804
19.  Event-related distress in kidney disease patients 
Non-dialysis-dependent chronic kidney disease (CKD) and dialysis-dependent Stage 5 CKD (CKD5) are associated with a significant physical and psychosocial burden. Little is known, however, about the impact of stressful life events on CKD and CKD5 patients. This study aimed to determine the prevalence of stressful life events in CKD and CKD5 patients and identify the factors correlated with high levels of event-related distress.
This cross-sectional study’s sample consisted of 181 patients (91 with non-dialysis-dependent CKD Stages 4 and 5, 90 with CKD5) who filled out the Impact of Event Scale (IES), which measures subjective distress related to stressful life events. Other measures included scores from the Medical Outcomes Study Short Form-36, Patient Health Questionnaire-9 (PHQ-9) and Dialysis Symptom Index (DSI).
One hundred and three subjects reported stressors on the IES. Almost half the stressors (49.5%) related to personal health; the rest fell into other categories. There were significant differences between the no stressor, low event-related distress and high event-related distress groups in age (P < 0.001), PHQ-9 score (P < 0.001) and DSI score (P = 0.002). After adjustment, PHQ-9 score was associated with high event-related distress [odds ratio (OR) 1.20, 95% confidence interval (CI) 1.10–1.32], as was DSI score (OR 1.04, 95% CI 1.02–1.07) in a separate model.
Event-related distress is common in CKD and CKD5 patients. High event-related distress is associated with worse depressive symptoms and greater somatic and emotional symptom burden, even with adjustments for age and gender. The renal practitioner may need to address patients’ event-related distress in order to provide optimal care.
PMCID: PMC3350338  PMID: 21624943
chronic kidney disease; depression; distress; end-stage renal disease; quality of life; symptoms
20.  Automated Clinical Reminders for Primary Care Providers in the Care of CKD: A Small Cluster-Randomized Controlled Trial 
Primary care physicians (PCPs) care for the majority of non-dialysis-dependent chronic kidney disease (CKD) patients. Studies suggest that PCPs may deliver suboptimal CKD care. One means to improve PCP treatment of CKD is clinical decision support systems (CDSS).
Study Design
Cluster randomized controlled trial
Setting & Participants
Thirty PCPs in a university-based outpatient general internal medicine practice and their 248 moderate to advanced CKD patients who had not been referred to a nephrologist.
Two CKD educational sessions were held for PCPs in both arms. The 15 intervention arm PCPs also received real-time automated electronic medical record alerts for patients with estimated glomerular filtration rates < 45 ml/min/1.73m2 recommending renal referral and urine albumin quantification if not done within the prior year.
Primary outcome was referral to a nephrologist; secondary outcomes were albuminuria/proteinuria assessment, CKD documentation, optimal blood pressure (i.e., < 130/80), and use of renoprotective medications.
The intervention and control arms did not differ in renal referrals (9.7% vs. 16.5%, respectively; between group difference, −6.8% (95% CI, −15.5% to 1.8%; P=0.1)) or proteinuria assessments (39.3% vs. 30.1%, respectively; between group difference, 9.2% (95% CI, −2.7% to 21.1%; P=0.1)). Among intervention and control group patients without a baseline proteinuria assessment, 27.7% versus 16.3%, respectively had one at follow-up (P=0.06). After controlling for clustering, these findings were largely unchanged and no significant differences were apparent between the groups.
Small single-center university based practice, use of a passive CDSS that required PCPs to trigger the electronic order set.
PCPs were willing to partake in a randomized trial of CDSS to improve outpatient CKD care. While CDSS may possess potential, larger studies are needed to further explore how best to deploy them to enhance CKD care.
PMCID: PMC3221894  PMID: 21982456
Chronic Kidney Disease; Primary Care Physician; Nephrologist; Quality of Care; Estimated Glomerular Filtration Rate; Renal Referral
21.  All-cause and cause-specific mortality associated with diabetes in prevalent hemodialysis patients 
BMC Nephrology  2012;13:130.
Diabetes is the most common risk factor for end-stage renal disease (ESRD) and has been associated with increased risk of death. In order to better understand the influence of diabetes on outcomes in hemodialysis, we examine the risk of death of diabetic participants in the HEMODIALYSIS (HEMO) study.
In the HEMO study, 823 (44.6%) participants were classified as diabetic. Using the Schoenfeld residual test, we found that diabetes violated the proportional hazards assumption. Based on this result, we fit two non-proportional hazard models: Cox’s time varying covariate model (Cox-TVC) that allows the hazard for diabetes to change linearly with time and Gray’s time-varying coefficient model.
Using the Cox-TVC, the hazard ratio (HR) for diabetes increased with each year of follow up (p = 0.02) for all cause mortality. Using Gray’s model, the HR for diabetes ranged from 1.41 to 2.21 (p <0.01). The HR for diabetes using Gray’s model exhibited a different pattern, being relatively stable at 1.5 for the first 3 years in the study and increasing afterwards.
Risk of death associated with diabetes in ESRD increases over time and suggests that an increasing risk of death among diabetes may be underappreciated when using conventional survival models.
PMCID: PMC3519533  PMID: 23025844
Cox regression; Diabetes; ESRD; Hemodialysis; Proportional hazard; Survival model; Time varying coefficient model; Time dependent covariate.
22.  Adherence to the Medical Regimen During the First Two Years After Lung Transplantation 
Transplantation  2008;85(2):193-202.
Despite the importance of adherence to the medical regimen for maximizing health after lung transplantation, no prospective studies report on rates or risk factors for nonadherence in this patient population. Whether adherence levels differ in lung versus other types of transplant recipients is unknown.
A total of 178 lung recipients and a comparison group of 126 heart recipients were enrolled. Adherence in nine areas was assessed in separate patient and family caregiver interviews 2, 7, 12, 18, and 24 months posttransplant. Potential risk factors for nonadherence were obtained at the initial assessment.
Cumulative incidence rates of persistent nonadherence (i.e., nonadherence at ≥2 consecutive assessments) were significantly lower (P < 0.05) in lung recipients than heart recipients for taking immunosuppressants (13% non-adherent vs. 21%, respectively), diet (34% vs. 56%), and smoking (1% vs. 8%). Lung recipients had significantly higher persistent nonadherence to completing blood work (28% vs. 17%) and monitoring blood pressure (70% vs. 59%). They had a high rate of spirometry nonadherence (62%; not measured in heart recipients). The groups did not differ in nonadherence to attending clinic appointments (27%), exercise (44%), or alcohol limitations (7%). In both groups, poor caregiver support and having only public insurance (e.g., Medicaid) increased nonadherence risk in all areas.
Lung recipients were neither uniformly better nor worse than heart recipients in adhering to their regimen. Lung recipients have particular difficulty with some home monitoring activities. Strategies to maximize adherence in both groups should build on caregiver support and on strengthening financial resources for patient healthcare requirements.
PMCID: PMC3387784  PMID: 18212623
Adherence; Lung transplantation; Heart transplantation; Risk factors
23.  Health-related quality of life in Hispanics with chronic kidney disease 
Translational Research  2009;155(4):157-163.
Health-related quality of life (HRQOL) is an important patient-reported outcome that has gained attention in research and clinical practice. In recent years, reports of chronic kidney disease (CKD) have increased. However, not much information is available for Hispanics with CKD, a group whose rates of incidents are on the rise. This review discusses the measurement of HRQOL in CKD, with a particular focus on issues pertaining to Hispanics. Future research directions also are discussed.
PMCID: PMC3386523  PMID: 20303462
24.  Impact of Sleep Quality on Cardiovascular Outcomes in Hemodialysis Patients: Results from the Frequent Hemodialysis Network Study 
American Journal of Nephrology  2011;33(5):398-406.
Poor sleep quality is a common, persistent, and important problem to patients with end-stage renal disease (ESRD). This report examines whether sleep quality is associated with dialysis treatment factors and other modifiable clinical factors in a large group of hemodialysis (HD) patients.
Cross-sectional analyses were conducted on baseline data collected from participants in the Frequent Hemodialysis Network trials. Sleep quality was measured using the Medical Outcomes Study Sleep Problems Index II (SPI II), a 9-item measure of sleep quality with higher scores reflecting poorer sleep quality.
The participants had an age of 51.2 ± 13.6 years, 61% were male, 38% were black, and 42% had diabetes. Higher pre-dialysis serum phosphorus (per 0.5 mg/ml) (OR 0.91; 95% CI 0.85, 0.96) and depression (OR 0.16; 95% CI 0.10, 0.25) were independently associated with decrements in sleep quality. There was also a difference in time to recovery from dialysis for the fourth versus the first SPI II quartile (5.1 h; p < 0.0001).
These findings underscore the link between sleep and daytime function and suggest that improving sleep may provide an opportunity to improve outcomes in ESRD. Whether sleep problems may be improved by reduction of serum phosphorus or treatment of depression in the HD population merits further investigation.
PMCID: PMC3080580  PMID: 21474924
Hemodialysis; Sleep; Quality of life; Cognitive function; Cardiac magnetic resonance imaging
25.  Nocturia, Sleep-Disordered Breathing, and Cardiovascular Morbidity in a Community-Based Cohort 
PLoS ONE  2012;7(2):e30969.
Nocturia has been independently associated with cardiovascular morbidity and all-cause mortality, but such studies did not adjust for sleep-disordered breathing (SDB), which may have mediated such a relationship. Our aims were to determine whether an association between nocturia and cardiovascular morbidity exists that is independent of SDB. We also determined whether nocturia is independently associated with SDB.
Methodology/Principal Findings
In order to accomplish these aims we performed a cross-sectional analysis of the Sleep Heart Health Study that contained information regarding SDB, nocturia, and cardiovascular morbidity in a middle-age to elderly community-based population. In 6342 participants (age 63±11 [SD] years, 53% women), after adjusting for known confounders such as age, body mass index, diuretic use, diabetes mellitus, alpha-blocker use, nocturia was independently associated with SDB (measured as Apnea Hypopnea index >15 per hour; OR 1.3; 95%CI, 1.2–1.5). After adjusting for SDB and other known confounders, nocturia was independently associated with prevalent hypertension (OR 1.23; 95%CI 1.08–1.40; P = 0.002), cardiovascular disease (OR 1.26; 95%CI 1.05–1.52; P = 0.02) and stroke (OR 1.62; 95%CI 1.14–2.30; P = 0.007). Moreover, nocturia was also associated with adverse objective alterations of sleep as measured by polysomnography and self-reported excessive daytime sleepiness (P<0.05).
Nocturia is independently associated with sleep-disordered breathing. After adjusting for SDB, there remained an association between nocturia and cardiovascular morbidity. Such results support screening for SDB in patients with nocturia, but the mechanisms underlying the relationship between nocturia and cardiovascular morbidity requires further study. MeSH terms: Nocturia, sleep-disordered breathing, obstructive sleep apnea, sleep apnea, polysomnography, hypertension.
PMCID: PMC3273490  PMID: 22328924

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