PMCCPMCCPMCC

Search tips
Search criteria 

Advanced

 
Logo of archdischArchives of Disease in ChildhoodVisit this articleSubmit a manuscriptReceive email alertsContact usBMJ
 
Arch Dis Child. 2007 November; 92(11): 1037–1038.
PMCID: PMC2083624

In neonates requiring intravascular volume resuscitation is the use of Gelofusine safe and efficacious?

Report by

Minesh Khashu, Lead Neonatologist, Poole Hospital NHS Trust, Poole, Dorset, UK; mineshkhashu@gmail.com

Velur Balasubramaniam, Neonatal Unit, Leicester Royal Infirmary, Leicester LE1 5WW, UK

A neonate born at 26 weeks and weighing 930 g underwent laparotomy on day 21 of life for perforation secondary to necrotising enterocolitis (NEC). He required fluid resuscitation during the procedure and Gelofusine was given rather than normal saline or blood products. We reviewed the evidence for the use of Gelofusine for volume replacement in neonates.

Structured clinical question

In neonates requiring intravascular volume replacement/resuscitation [patient] is use of Gelofusine [intervention] efficacious and safe [outcome]?

Search strategy and outcome

Search terms: “Gelofusine”, “Gelatin” and “Synthetic Colloids”.

Search literature: PubMed and Medline 1966–2005, EMBASE 1974–2005, Cinahl 1982–2005 using Dialog Data Star, Google Scholar, Proquest journals.

Search limit: To human studies and English literature.

Neonatal and paediatric studies

See table 11.

Table thumbnail
Table 1 Neonatal and paediatric studies

Adult studies

See supplemental table 11 available at http://adc.bmj.com/supplemental.

Commentary

Gelofuscine is a synthetic colloid, which, in recent years, has been increasingly used for volume replacement. The advantages of Gelofuscine are that it is less expensive than other synthetic colloids, is readily available and can be stored for long periods without degradation.3 4 The increased usage is also, perhaps, secondary to perceived increased risk associated with albumin infusions and other blood products.5–7

The effects of Gelofuscine or alternative volume expansion in preterm infants have been subjected to a systematic review which included seven randomised controlled trial (RCTs).1 Out of these only one RCT investigated the use of Gelofusine for volume expansion in neonates. The Northern Neonatal Nursing Initiative (NNNI) Trial Group in this multicentre study compared the effects of prophylactic administration of fresh frozen plasma (FFP), gelatine and glucose on early mortality and morbidity in preterm infants. We did not find any evidence in the literature regarding objective evaluation of the efficacy of Gelofuscine for volume resuscitation/replacement in neonates. With regard to safety, the NNNI trial did not demonstrate any adverse short term outcomes related to Gelofuscine use.8 Developmental outcome at 2 years was also similar in the three groups.9 However, the Cochrane review by Osborn et al noted that Gelofuscine use or no treatment was associated with increased risk of developing NEC (relative risk (RR) 4.92) when compared to FFP.1 Although no significant differences in mortality or disability were found in this study and a wide confidence interval suggests an underpowered study, this finding warrants further research.

In view of the lack of appropriate studies in neonates and to further elucidate our clinical question, we extended our search to studies in the paediatric and adult population. One RCT has compared volume expansion with Gelofusine and albumin in children with severe malaria.2 Akech et al noted no significant difference in the resolution of shock or acidosis between the two groups, but fatal neurological events were more common in the group receiving Gelofusine. Five RCTs have reported on the use of Gelofusine in adults10–14 (see supplemental table 11 available at http://adc.bmj.com/supplemental). Allison et al compared the use of gelatine and HES for resuscitation in patients with blunt trauma and suggested that Gelofuscine was associated with a worse post‐trauma capillary leak.10 This may be important in newborns with capillary leak syndrome such as sepsis and NEC, but relevance at present is conjectural. Schortgen et al investigated the effects of gelatine and HES on renal function in adults with severe sepsis and suggested that gelatine is safer in terms of renal function.12 No impairment of haemostasis was noted by Haisch et al following Gelofuscine use in adults undergoing major abdominal surgery.13 Rittoo et al in an RCT in adults undergoing abdominal aortic aneurysm surgery noted inferior gas exchange and lung compliance and poorer small lung injury score in the Gelofusine group compared to HES.11 Whether this has any implications in neonates with unstable lung function and in worsening lung damage needs to be elucidated.

Adult studies suggest that Gelofuscine has less antigenic properties and thus a lower chance of hypersensitivity reactions. The other potential disadvantages include the possibility of altered haemostasis15 16 and proteinuria.17 18 The relevance of these findings to the neonatal population has not been explored.

Although Gelofuscine is readily available and cheap, and less monitoring is required during infusions, there is no evidence to support its efficacy for use in volume expansion in neonates. Moreover, considering the potential side effects in preterm neonates, it should be used with caution until further studies are available to prove its safety and efficacy. This is especially pertinent considering the lack of evidence of any potential superiority of various colloids over normal saline for volume replacement.19

Clinical bottom line

  • There is lack of evidence for the efficacy of Gelofuscine for volume resuscitation in neonates.
  • There is insufficient evidence to support or refute the use of Gelofuscine over fresh frozen plasma or dextrose or no fluid therapy in the context of prophylactic volume replacement in neonates. (Grade B)
  • Weak evidence suggests an increased risk of necrotising enterocolitis with the use of Gelofuscine in neonates. (Grade B)
  • Gelofuscine use should be restricted to a clinical trial setting. (Grade A)
  • A large RCT is needed to evaluate the efficacy and safety of Gelofuscine for volume replacement in neonates.

References

1. Osborn D A, Evans N. Early volume expansion for prevention of morbidity and mortality in very preterm infants. Cochrane Database Syst Rev 2004;(2):CD002055. [PubMed]
2. Akech S, Gwer S, Idro R. et al Volume expansion with albumin compared to Gelofusine in children with severe malaria: results of a controlled trial. PLoS Clin Trials 2006;1(5):e21. [PMC free article] [PubMed]
3. Saddler J M, Horsey P J. The new generation gelatins. A review of their history, manufacture and properties. Anaesthesia 1987;42(9):998-1004. [PubMed]
4. Salmon J B, Mythen M G., . Pharmacology and physiology of colloids. Blood Rev 1993;7(2):114-20. [PubMed]
5. Martin G. Conflicting clinical trial data lesson from albumin. Crit Care 2005;9(6):649-50. [PMC free article] [PubMed]
6. Cook D. Is albumin safe? N Engl J Med 2004;350(22):2294-6. [PubMed]
7. Alderson P, Bunn F, Li Wan A Po. et al Human albumin solution for resuscitation and volume expansion in critically ill patients. Cochrane Database Syst Rev 2004;(4):CD001208. [PubMed]
8. The Northern Neonatal Nursing Initiative [NNNI] Trial Group. A randomized trial comparing the effect of prophylactic intravenous fresh frozen plasma, gelatin or glucose on early mortality and morbidity in preterm babies. Eur J Paediatrics 1996;155(7):580-8. [PubMed]
9. Tin W, Wariyar U, Hey E. et al Randomised trial of prophylactic early fresh-frozen plasma or gelatin or glucose in preterm babies: outcome at 2 years. Lancet 1996;348:229-32. [PubMed]
10. Allison K P, Gosling P, Jones S. et al Randomised trial of hydroxyethyl starch versus gelatine for trauma resuscitation. J Trauma 1999;47(6):1114-21. [PubMed]
11. Rittoo D, Gosling P, Burnley S. et al Randomised study comparing the effects of hydroxyethyl starch solution with Gelofuscine on pulmonary function in patients undergoing abdominal aortic aneurysm surgery. Br J Anaesth 2004;92(1):61-6. [PubMed]
12. Schortgen F, Lacherade J-C, Bruneel F. et al Effects of hydroxyethylstarch and gelatin on renal function in severe sepsis: a multicentre randomised study. Lancet 2001;357:911-16. [PubMed]
13. Haisch G, Boldt J, Krebs C. et al The influence of intravascular volume therapy with a new hydroxyethyl starch preparation (6% HES 130/0.4) on coagulation in patients undergoing major abdominal surgery. Anesth Analg 2001;92(3):565-71. [PubMed]
14. Rittoo D, Gosling P, Simms M H. et al The effects of hydroxyethyl starch compared with Gelofuscine on activated endothelium and the systemic inflammatory response following aortic aneurysm repair. Eur J Vasc Endovasc Surg 2005;30(5):520-4. [PubMed]
15. Evans P A, Glenn J R, Heptinstall S. et al Effects of gelatine-based resuscitation fluids on platelet aggregation. Br J Anaesth 1988;81(2):198-202. [PubMed]
16. Coats T J, Brazil E, Heron M. The effects of commonly used resuscitation fluids on whole blood coagulation. Emerg Med J 2006;23(7):546-9. [PMC free article] [PubMed]
17. Lundsgaard‐Hansen P, Tschirren B. Clinical experience with 120000 units of modified fluid gelatin. Dev Biol Stand 1980;48:251-6. [PubMed]
18. ten Dam M A, Branten A J, Klasen I S. et al The gelatine-derived plasma substitute Gelofuscine causes low-molecular weight proteinuria by decreasing tubular protein reabsorption. J Crit Care 2001;16(3):115-20. [PubMed]
19. Boluyt N, Bollen W, Bos A P. et al Fluid resuscitation in neonatal and pediatric hypovolemic shock: a Dutch Pediatric Society evidence-based clinical practice guideline. Intensive Care Med 2006;32(7):995-1003. [PubMed]

Articles from Archives of Disease in Childhood are provided here courtesy of BMJ Publishing Group