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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article numberR299
JournalCritical Care
Volume17
Issue number6
DOIs
StatePublished - Dec 23 2013
Externally publishedYes

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Hydroxyethyl Starch Derivatives
Resuscitation
Clinical Trials
Wounds and Injuries
Confidence Intervals
Length of Stay
Adult Respiratory Distress Syndrome
Intensive Care Units
Mortality
Odds Ratio
Kidney
Tissue Survival
Ringer's lactate
Colloids
Lung Injury
Hospital Mortality
Starch
Creatinine
Ringer's solution

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine
  • Medicine(all)

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Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury : A randomized, controlled, double-blind clinical trial. / Béchir, Markus; Puhan, Milo A.; Fasshauer, Mario; Schuepbach, Reto A.; Stocker, Reto; Neff, Thomas A.

In: Critical Care, Vol. 17, No. 6, R299, 23.12.2013.

Research output: Contribution to journalArticle

Béchir, Markus ; Puhan, Milo A. ; Fasshauer, Mario ; Schuepbach, Reto A. ; Stocker, Reto ; Neff, Thomas A. / Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury : A randomized, controlled, double-blind clinical trial. In: Critical Care. 2013 ; Vol. 17, No. 6.
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title = "Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6{\%}) in severe burn injury: A randomized, controlled, double-blind clinical trial",
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.",
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T1 - Early fluid resuscitation with hydroxyethyl starch 130/0.4 (6%) in severe burn injury

T2 - A randomized, controlled, double-blind clinical trial

AU - Béchir, Markus

AU - Puhan, Milo A.

AU - Fasshauer, Mario

AU - Schuepbach, Reto A.

AU - Stocker, Reto

AU - Neff, Thomas A.

PY - 2013/12/23

Y1 - 2013/12/23

N2 - 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.

AB - 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.

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