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1.  Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2) 
Trials  2014;15(1):507.
Background
Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation (IMV) and the most commonly prescribed treatment in intensive care units (ICUs). International guidelines consistently indicate that enteral nutrition (EN) should be preferred over parenteral nutrition (PN) whenever possible and started as early as possible. However, no adequately designed study has evaluated whether a specific nutritional modality is associated with decreased mortality. The primary goal of this trial is to assess the hypothesis that early first-line EN, as compared to early first-line PN, decreases day 28 all-cause mortality in patients receiving IMV and vasoactive drugs for shock.
Methods/Design
The NUTRIREA-2 study is a multicenter, open-label, parallel-group, randomized controlled trial comparing early PN versus early EN in critically ill patients requiring IMV for an expected duration of at least 48 hours, combined with vasoactive drugs, for shock. Patients will be allocated at random to first-line PN for at least 72 hours or to first-line EN. In both groups, nutritional support will be started within 24 hours after IMV initiation. Calorie targets will be 20 to 25 kcal/kg/day during the first week, then 25 to 30 kcal/kg/day thereafter. Patients receiving PN may be switched to EN after at least 72 hours in the event of shock resolution (no vasoactive drugs for 24 consecutive hours and arterial lactic acid level below 2 mmol/L). On day 7, all patients receiving PN and having no contraindications to EN will be switched to EN. In both groups, supplemental PN may be added to EN after day 7 in patients with persistent intolerance to EN and inadequate calorie intake. We plan to recruit 2,854 patients at 44 participating ICUs.
Discussion
The NUTRIREA-2 study is the first large randomized controlled trial designed to assess the hypothesis that early EN improves survival compared to early PN in ICU patients. Enrollment started on 22 March 2013 and is expected to end in November 2015.
Trial registration
ClinicalTrials.gov Identifier: NCT01802099 (registered 27 February 2013)
doi:10.1186/1745-6215-15-507
PMCID: PMC4307984  PMID: 25539571
Critical illness; Enteral nutrition; Mechanical ventilation; Mortality; Nosocomial infection; Parenteral nutrition; Shock; Vasoactive drugs
2.  Ethical reflections on end-of-life signs and symptoms in the intensive care setting: a place for neuromuscular blockers? 
The death of a loved one is often an ordeal and a tragedy for those who witness it, as death is not merely the end of a life, but also the end of an existence, the loss of a unique individual who is special and irreplaceable. In some situations, end-of-life signs, such as agonal gasps, can be an almost unbearable “sight” because the physical manifestations are hard to watch and can lead to subjective interpretation and irrational fears. Ethical unease arises as the dying patient falls prey to death throes and to the manifestations of ebbing life and the physician can only stand by and watch. From this point on, medicine can put an end to suffering by the use of neuromuscular blockade, but in so doing life ceases at the same time. It is difficult, however, not to respond to the distress of loved ones and caregivers. The ethical problem then becomes the shift from the original ethical concern, i.e. the dying patient, to the patient’s loved ones. Is such a rupture due to a difference in nature or a difference in degree, given that the dying patient remains a person and not a thing as long as the body continues to lead its own life, expressed through movement and sound? Because there cannot be any simple and unequivocal answer to this question, the SRLF Ethics Commission is offering ethical reflections on end-of-life signs and symptoms in the intensive care setting, and on the use of neuromuscular blockade in this context, with presentations on the subject by two philosophers and members of the SRLF Ethics Commission, Ms Lise Haddad and Prof Dominique Folscheid. The SRLF Ethics Commission hopes to provide food for thought for everyone on this topic, which undoubtedly calls for further contributions, the aim being not to provide ready-made solutions or policy, but rather to allow everyone to ponder this question in all conscience.
doi:10.1186/2110-5820-4-23
PMCID: PMC4098689  PMID: 25045580
Ethics; End of life; Critical care; Gasps
3.  End of life in the intensive care unit: should French law be adapted? 
Background
Longstanding concerns regarding end of life in the ICU led in France to the publication of guidelines, updated in 2009, that take into account the insights provided by a recent law (Leonetti’s law) regarding patients’ rights. After the French President asked a specific expert to review end of life issues, the French Intensive Care Society (SRLF) surveyed their members (doctors and paramedics) about various aspects of end of life in the ICU.
Methods
SRLF members were invited to respond to a questionnaire, sent by Email, designed to assess their knowledge of Leonetti’s law and to determine how many caregivers would agree with the authorization of lethal drug administration in selected end of life situations.
Results
Questionnaires returned by 616 (23%) of 2,700 members were analyzed. Most members (82.5%) reported that they had a good knowledge of Leonetti’s law, which most (88%) said they have often applied. One third of respondents had received ‘assisted death’ requests from patients and more than 50% from patients’ relatives. One quarter of respondents had experienced the wish to give lethal drugs to end of life patients. Assuming that palliative care in the ICU is well-managed, 25.7% of the respondents would approve a law authorizing euthanasia, while 26.5% would not. Answers were influenced by the fear of a possible risk of abuse. Doctors and nurses answered differently.
Conclusion
ICU caregivers appear to be well acquainted with Leonetti’s law. Nevertheless, in selected clinical situations with suitable palliative care, one quarter of respondents were in favor of a law authorizing administration of lethal drugs to patients.
doi:10.1186/2110-5820-4-6
PMCID: PMC4015966  PMID: 24568144
Euthanasia; Palliative care; End of life; Intensive care unit
4.  Gentamicin in Hemodialyzed Critical Care Patients: Early Dialysis after Administration of a High Dose Should Be Considered 
Gentamicin is a widely used antibiotic in the intensive care unit (ICU). Its dosage is difficult to adapt to hemodialyzed ICU patients. The FDA-approved regimen consists of the administration of 1 to 1.7 mg/kg of gentamicin at the end of each dialysis session. Better pharmacokinetic management could be obtained if gentamicin were administered just before the dialysis session. We performed Monte Carlo simulations (MCS) to determine the best gentamicin pharmacokinetic profile (high peak and low trough concentrations). Then, 6 mg/kg of gentamicin was infused into 10 ICU patients over a period of 30 min. A 4-h-long hemodialysis session was started 30 min after the end of the infusion. Pharmacokinetic samples were regularly collected over 24 h. A one-compartment model with zero-order input and first-order elimination was developed in Nonmem version VI to analyze patients' measured gentamicin concentration-versus-time profiles. Finally, additional MCS were performed to compare the regimen chosen with the FDA-approved gentamicin regimen. High peak concentrations (Cmax, 31.8 ± 16.8 mg/liter) were achieved. The estimated C24 and C48 values (concentrations 24 and 48 h, respectively, after the beginning of the infusion) were 4.1 ± 2.3 and 1.8 ± 1.2 mg/liter, respectively. The volume of distribution was 0.21 ± 0.06 liter/kg. MCS confirmed that the dosing regimen chosen achieved the target Cmax whereas the FDA-approved regimen did not (31.0 ± 10.9 versus 8.8 ± 3.1 mg · liter−1). Moreover, the C24 values were similar while the AUC0-24 values were moderately increased (190.8 ± 65.0 versus 135 ± 42.2 mg · h · liter−1). Therefore, administration of 6 mg/kg of gentamicin before hemodialysis to critically ill patients achieves a high Cmax and an acceptable AUC, maximizing pharmacokinetic/pharmacodynamic endpoints.
doi:10.1128/AAC.01762-12
PMCID: PMC3553715  PMID: 23229487
5.  Benefits of an early cooling phase in continuous renal replacement therapy for ICU patients 
Background
Lowering the temperature setting in the heating device during continuous venovenous hemofiltration (CVVH) is an option. The purpose of this study was to determine the effects on body temperature and hemodynamic tolerance of two different temperature settings in the warming device in patients treated with CVVH.
Methods
Thirty patients (mean age: 66.5 years; mean SAPS 2: 55) were enrolled in a prospective crossover randomized study. After a baseline of 2 h at 38°C, the heating device was randomly set to 38°C (group A) and 36°C (group B) for 6 h. Then, the temperatures were switched to 36°C in group A and to 38°C in group B for another 6 h. Hemodynamic parameters and therapeutic interventions to control the hemodynamics were recorded.
Results
There was no significant change in body temperature in either group. During the first 6 h, group B patients showed significantly increased arterial pressure (p = 0.01) while the dosage of catecholamine was significantly decreased (p = 0.04). The number of patients who required fluid infusion or increase in catecholamine dosage was similar. During the second period of the study, hemodynamic parameters were unchanged in both groups.
Conclusions
In patients undergoing CVVH, warming of the substitute over 36°C had no impact on body temperature. We showed that setting the fluid temperature at 36°C for a period of time early in the procedure is beneficial in terms of increased mean arterial pressure and decreased catecholamine infusion dosage.
doi:10.1186/2110-5820-2-40
PMCID: PMC3488546  PMID: 22913879
Renal replacement therapy; Hemofiltration; Hemodynamic; Rewarming device; Temperature
6.  Contribution of the ethics committee of the French Intensive Care Society to describing a scenario for implementing organ donation after Maastricht type III cardiocirculatory death in France 
French law allows organ donation after death due to cardiocirculatory arrest. In the Maastricht classification, type III non-heart-beating donors are those who experience cardiocirculatory arrest after the withdrawal of life-sustaining treatments. French authorities in charge of regulating organ donation (Agence de la Biomédecine, ABM) are considering organ collection from Maastricht type III donors. We describe a scenario for Maastricht type III organ donation that fully complies with the ethical norms governing care to dying patients. That organ donation may occur after death should have no impact on the care given to the patient and family. The dead-donor rule must be followed scrupulously: the organ retrieval procedure must neither cause nor hasten death. The decision to withdraw life-sustaining treatments, withdrawal modalities, and care provided to the patient and family must adhere strictly to the requirements set forth in patient-rights legislation (the 2005 Léonetti law in France) and should not be influenced in any way by the possibility of organ donation. A major ethical issue regarding the family is how best to transition from discussing treatment-withdrawal decisions to discussing possible organ retrieval for donation should the patient die rapidly after treatment withdrawal. Close cooperation between the healthcare team and the organ retrieval team is crucial to minimize the distress of family members during this transition. Modalities for implementing Maastricht type III organ donation are discussed here, including the best location for withdrawing life-sustaining treatments (operating room or intensive care unit).
doi:10.1186/2110-5820-2-23
PMCID: PMC3475084  PMID: 22747673
Organ donation; Treatment withdrawal; Cardiocirculatory arrest
7.  Catabacter hongkongensis Bacteremia with Fatal Septic Shock 
Emerging Infectious Diseases  2011;17(7):1330-1331.
doi:10.3201/eid1707.101773
PMCID: PMC3381405  PMID: 21762611
bacteria; septic shock; bacteremia; Catabacter hongkongensis; letter
8.  Gender difference and sex hormone production in rodent renal ischemia reperfusion injury and repair 
Background
Several lines of evidence suggest a protective effect of female sex hormones in several organs subjected to ischemia-reperfusion injury. The aim of the study was to investigate sex hormone production in male rats after a renal ischemia-reperfusion sequence and analyze the influence of gender differences on tissue remodelling during the recovery process.
Method
Age-matched sexually mature male and female rats were subjected to 60 min of renal unilateral ischemia by pedicle clamping with contralateral nephrectomy and followed for 1 or 5 days after reperfusion. Plasma creatinine, systemic testosterone, progesterone and estradiol levels were determined. Tubular injury, cell proliferation and inflammation, were evaluated as well as proliferating cell nuclear antigen, vimentin and translocator protein (TSPO) expressions by immunohistochemistry.
Results
After 1 and 5 days of reperfusion, plasma creatinine was significantly higher in males than in females, supporting the high mortality in this group. After reperfusion, plasma testosterone levels decreased whereas estradiol significantly increased in male rats. Alterations of renal function, associated with tubular injury and inflammation persisted during the 5 days post-ischemia-reperfusion, and a significant improvement was observed in females at 5 days of reperfusion. Proliferating cell nuclear antigen and vimentin expression were upregulated in kidneys from males and attenuated in females, in parallel to injury development. TSPO expression was transiently increased in proximal tubules in male rats.
Conclusions
After ischemia, renal function recovery and tissue injury is gender-dependent. These differences are associated with a modulation of sex hormone production and a modification of tissue remodeling and proliferative cell processes.
doi:10.1186/1476-9255-8-14
PMCID: PMC3127739  PMID: 21658244
9.  Helicobacter pylori infection is not associated with an increased hemorrhagic risk in patients in the intensive care unit 
Critical Care  2006;10(3):R77.
Introduction
The potential role of Helicobacter pylori in acute stress ulcer in patients in an intensive care unit (ICU) is controversial. The aim of this study was to determine the frequency of H. pylori infection in ICU patients by antigen detection on rectal swabs, and to analyze the potential relationship between the presence of H. pylori and the risk of digestive gastrointestinal bleeding.
Methods
In this prospective, multicenter, epidemiological study, the inclusion criteria were as follows: patients admitted to the 12 participating ICU for at least two days, who were free of hemorrhagic shock and did not receive more than four units of red blood cells during the day before or the first 48 hours after admission to the ICU. Rectal swabs were obtained within the first 24 hours of admission to the ICU and were tested for H. pylori antigens with the ImmunoCard STAT! HpSA kit. The following events were analyzed according to H. pylori status: gastrointestinal bleeding, unexplained decline in hematocrit, and the number of red cell transfusions.
Results
The study involved 1,776 patients. Forty-nine patients (2.8%) had clinical evidence of upper digestive bleeding. Esophagogastroduodenoscopy was performed in 7.6% of patients. Five hundred patients (28.2%) required blood transfusion. H. pylori antigen was detected in 6.3% of patients (95% confidence interval 5.2 to 7.5). H. pylori antigen positivity was associated with female sex (p < 0.05) and with a higher Simplified Acute Physiology Score II (SAPS II; p < 0.05). H. pylori antigen status was not associated with the use of fiber-optic gastroscopy, the need for red cell transfusions, or the number of red cell units infused.
Conclusion
This large study reported a small percentage of H. pylori infection detected with rectal swab sampling in ICU patients and showed that the patients infected with H. pylori had no additional risk of gastrointestinal bleeding. Thus H. pylori does not seem to have a major role in the pathogenesis of acute stress ulcer in ICU patients.
doi:10.1186/cc4920
PMCID: PMC1550927  PMID: 16704741

Results 1-9 (9)