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Critical Care

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Open Access 01-12-2013 | Research

Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury: a randomized, controlled, double-blind clinical trial

Authors: Markus Béchir, Milo A Puhan, Mario Fasshauer, Reto A Schuepbach, Reto Stocker, Thomas A Neff

Published in: Critical Care | Issue 6/2013

Abstract

Introduction

There are limited data on the efficacy of early fluid resuscitation with third-generation hydroxyethyl starch (HES 130) in burn injury. Adverse effects of HES on survival and organ function have been reported.

Methods

In this randomized, controlled, double-blind trial, 48 patients with severe burn injury were assigned to receive either lactated Ringer’s solution plus 6% HES 130/0.4 in a ratio of 2:1 or lactated Ringer’s solution with no colloid supplement for the first 72 hours. Primary outcome parameter was the group difference of administered total fluid from intensive care unit (ICU) admission up to day 3. Secondary outcomes included kidney and lung injury and failure, length of stay, and mortality.

Results

Three-day totals of administered resuscitation fluid (medians) were 21,190 mL in the lactated Ringer’s group and 19,535 mL in the HES group (HES: −1,213 mL; P = 0.39). Creatinine levels from day 1 to 3 (HES: +0.4 μmol/L; 95% confidence interval (CI) −18.7 to 19.5; P = 0.97) and urinary outputs from day 1 to 3 (HES: −58 mL; 95% CI −400 to 283; P = 0.90) were not different. Six patients in each group developed acute respiratory distress syndrome (ARDS) (risk ratio 0.96; 95% CI 0.35 to 2.64; P = 0.95). Length of ICU stay (HES vs. lactated Ringer’s: 28 vs. 24 days; P = 0.80) and length of hospital stay (31 vs. 29 days; P = 0.57) were similar. Twenty-eight-day mortality was 4 patients in each group (risk ratio 0.96; 95% CI 0.27 to 4.45; P = 0.95), and in-hospital mortality was 8 in the HES group vs. 5 patients in the lactated Ringer’s group (hazard ratio 1.86; 95% CI 0.56 to 6.19; P = 0.31).

Conclusions

There was no evidence that early fluid resuscitation with balanced HES 130/0.4 (6%) in addition to lactated Ringer’s solution would lead to a volume-sparing effect in severe burn injury. Together with the findings that early renal function, incidence of ARDS, length of stay, and mortality were not negatively influenced by HES in this setting, balanced HES 130/0.4 (6%) plus lactated Ringer’s solution could not be considered superior to lactated Ringer’s solution alone.

Trial registration

ClinicalTrials.gov NCT01012648

Available only for authorised users

Pitt RM, Parker JC, Jurkovich GJ, Taylor AE, Curreri PW: Analysis of altered capillary pressure and permeability after thermal injury. J Surg Res 1987, 42: 693-702. 10.1016/0022-4804(87)90013-8CrossRefPubMed

Youn YK, LaLonde C, Demling R: The role of mediators in the response to thermal injury. World J Surg 1992, 16: 30-36. 10.1007/BF02067111CrossRefPubMed

Warden GD: Burn shock resuscitation. World J Surg 1992, 16: 16-23. 10.1007/BF02067109CrossRefPubMed

Yowler CJ, Fratianne RB: Current status of burn resuscitation. Clin Plast Surg 2000, 27: 1-10.PubMed

Cocks AJ, O’Connell A, Martin H: Crystalloids, colloids and kids: a review of paediatric burns in intensive care. Burns 1998, 24: 717-724. 10.1016/S0305-4179(98)00102-8CrossRefPubMed

Holm C: Resuscitation in shock associated with burns. Tradition or evidence-based medicine? Resuscitation 2000, 44: 157-164. 10.1016/S0300-9572(00)00159-3CrossRefPubMed

Baxter CR: Fluid volume and electrolyte changes of the early postburn period. Clin Plast Surg 1974, 1: 693-703.PubMed

Baxter CR, Marvin JA, Curreri PW: Early management of thermal burns. Postgrad Med 1974, 55: 131-139.PubMed

Cochrane Injuries Group Albumin Reviewers: Human albumin administration in critically ill patients: systematic review of randomised controlled trials. BMJ 1998, 317: 235-240. 10.1136/bmj.317.7153.235CrossRef

10.

Ennis JL, Chung KK, Renz EM, Barillo DJ, Albrecht MC, Jones JA, Blackbourne LH, Cancio LC, Eastridge BJ, Flaherty SF, Dorlac WC, Kelleher KS, Wade CE, Wolf SE, Jenkins DH, Holcomb JB: Joint Theater Trauma System implementation of burn resuscitation guidelines improves outcomes in severely burned military casualties. J Trauma 2008, 64: S146-S151. Discussion S151-142 10.1097/TA.0b013e318160b44cCrossRefPubMed

11.

Wharton SM, Khanna A: Current attitudes to burns resuscitation in the UK. Burns 2001, 27: 183-184. 10.1016/S0305-4179(00)00097-8CrossRefPubMed

12.

Bechir M, Puhan MA, Neff SB, Guggenheim M, Wedler V, Stover JF, Stocker R, Neff TA: Early fluid resuscitation with hyperoncotic hydroxyethyl starch 200/0.5 (10%) in severe burn injury. Crit Care 2010, 14: R123. 10.1186/cc9086PubMedCentralCrossRefPubMed

13.

Vlachou E, Gosling P, Moiemen NS: Hydroxyethylstarch supplementation in burn resuscitation-a prospective randomised controlled trial. Burns 2010, 36: 984-991. 10.1016/j.burns.2010.04.001CrossRefPubMed

14.

Bernard GR, Artigas A, Brigham KL, Carlet J, Falke K, Hudson L, Lamy M, Legall JR, Morris A, Spragg R: The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med 1994, 149: 818-824. 10.1164/ajrccm.149.3.7509706CrossRefPubMed

15.

Cancio LC, Chavez S, Alvarado-Ortega M, Barillo DJ, Walker SC, McManus AT, Goodwin CW: Predicting increased fluid requirements during the resuscitation of thermally injured patients. J Trauma 2004, 56: 404-413. discussion 413–404 10.1097/01.TA.0000075341.43956.E4CrossRefPubMed

16.

Cartotto RC, Innes M, Musgrave MA, Gomez M, Cooper AB: How well does the Parkland formula estimate actual fluid resuscitation volumes? J Burn Care Rehabil 2002, 23: 258-265. 10.1097/00004630-200207000-00006CrossRefPubMed

17.

Friedrich JB, Sullivan SR, Engrav LH, Round KA, Blayney CB, Carrougher GJ, Heimbach DM, Honari S, Klein MB, Gibran NS: Is supra-Baxter resuscitation in burn patients a new phenomenon? Burns 2004, 30: 464-466. 10.1016/j.burns.2004.01.021CrossRefPubMed

18.

Jungheinrich C, Scharpf R, Wargenau M, Bepperling F, Baron JF: The pharmacokinetics and tolerability of an intravenous infusion of the new hydroxyethyl starch 130/0.4 (6%, 500 mL) in mild-to-severe renal impairment. Anesth Analg 2002, 95: 544-551. Table of contentsPubMed

19.

Thompson WL, Fukushima T, Rutherford RB, Walton RP: Intravascular persistence, tissue storage, and excretion of hydroxyethyl starch. Surg Gynecol Obstet 1970, 131: 965-972.PubMed

20.

De Labarthe A, Jacobs F, Blot F, Glotz D: Acute renal failure secondary to hydroxyethylstarch administration in a surgical patient. Am J Med 2001, 111: 417-418. 10.1016/S0002-9343(01)00873-7CrossRefPubMed

21.

Waldhausen P, Kiesewetter H, Leipnitz G, Scielny J, Jung F, Bambauer R, von Blohn G: Hydroxyethyl starch-induced transient renal failure in preexisting glomerular damage. Acta Med Austriaca 1991, 18: 52-55.PubMed

22.

James MF, Michell WL, Joubert IA, Nicol AJ, Navsaria PH, Gillespie RS: Resuscitation with hydroxyethyl starch improves renal function and lactate clearance in penetrating trauma in a randomized controlled study: the FIRST trial (Fluids in Resuscitation of Severe Trauma). Br J Anaesth 2011, 107: 693-702. 10.1093/bja/aer229CrossRefPubMed

23.

Boussekey N, Darmon R, Langlois J, Alfandari S, Devos P, Meybeck A, Chiche A, Georges H, Leroy O: Resuscitation with low volume hydroxyethylstarch 130 kDa/0.4 is not associated with acute kidney injury. Crit Care 2010, 14: R40. 10.1186/cc8920PubMedCentralCrossRefPubMed

24.

Dubin A, Pozo MO, Casabella CA, Murias G, Palizas F Jr, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C: Comparison of 6% hydroxyethyl starch 130/0.4 and saline solution for resuscitation of the microcirculation during the early goal-directed therapy of septic patients. J Crit Care 2010, 25: 659. e651-658.CrossRef

25.

Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Åneman A, Madsen KR, Møller MH, Elkjær JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Søe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjældgaard AL, Fabritius ML, Mondrup F, Pott FC, Møller TP, Winkel P, Wetterslev J, 6S Trial Group; Scandinavian Critical Care Trials Group: Hydroxyethyl starch 130/0.42 versus Ringer’s acetate in severe sepsis. N Engl J Med 2012, 367: 124-134. 10.1056/NEJMoa1204242CrossRefPubMed

26.

Myburgh JA, Finfer S, Bellomo R, Billot L, Cass A, Gattas D, Glass P, Lipman J, Liu B, McArthur C, McGuinness S, Rajbhandari D, Taylor CB, Webb SA, CHEST Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group: Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med 2012, 367: 1901-1911. 10.1056/NEJMoa1209759CrossRefPubMed

27.

Hartog CS, Kohl M, Reinhart K: A systematic review of third-generation hydroxyethyl starch (HES 130/0.4) in resuscitation: safety not adequately addressed. Anesth Analg 2011, 112: 635-645. 10.1213/ANE.0b013e31820ad607CrossRefPubMed

28.

Zarychanski R, Abou-Setta AM, Turgeon AF, Houston BL, McIntyre L, Marshall JC, Fergusson DA: Association of hydroxyethyl starch administration with mortality and acute kidney injury in critically ill patients requiring volume resuscitation: a systematic review and meta-analysis. JAMA 2013, 309: 678-688. 10.1001/jama.2013.430CrossRefPubMed

29.

Perel P, Roberts I, Ker K: Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev 2013., 2: CD000567

30.

Gattas DJ, Dan A, Myburgh J, Billot L, Lo S, Finfer S: Fluid resuscitation with 6% hydroxyethyl starch (130/0.4 and 130/0.42) in acutely ill patients: systematic review of effects on mortality and treatment with renal replacement therapy. Intensive Care Med 2013, 39: 558-568. 10.1007/s00134-013-2840-0CrossRefPubMed

31.

Haase N: Systematic review not influenced by Boldt’s work. BMJ 2013, 346: f2280. 10.1136/bmj.f2280CrossRefPubMed

32.

Haase N, Perner A, Hennings LI, Siegemund M, Lauridsen B, Wetterslev M, Wetterslev J: Hydroxyethyl starch 130/0.38–0.45 versus crystalloid or albumin in patients with sepsis: systematic review with meta-analysis and trial sequential analysis. BMJ 2013, 346: f839. 10.1136/bmj.f839PubMedCentralCrossRefPubMed

Title: Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury: a randomized, controlled, double-blind clinical trial
Authors: Markus Béchir
Milo A Puhan
Mario Fasshauer
Reto A Schuepbach
Reto Stocker
Thomas A Neff
Publication date: 01-12-2013
Publisher: BioMed Central
Published in: Critical Care / Issue 6/2013
Electronic ISSN: 1364-8535
DOI: https://doi.org/10.1186/cc13168

At a glance: The STEP trials

Springer Medicine

Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury: a randomized, controlled, double-blind clinical trial

Abstract

Introduction

Methods

Results

Conclusions

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusions

Trial registration

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