Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care

John Myburgh, Simon Finfer, Rinaldo Bellomo, Laurent Billot, Alan Cass, David Gattas, Parisa Glass, Jeffrey Lipman, Bette Liu, Colin McArthur, Shay McGuinness, Dorrilyn Rajbhandari, Colman Taylor, Steven Webb

    Research output: Contribution to journalArticleResearchpeer-review

    Abstract

    Background: The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have not been fully evaluated, and adverse effects of HES on survival and renal function have been reported.

    Methods: We randomly assigned 7000 patients who had been admitted to an intensive care unit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride or 0.9% sodium chloride (saline) for all fluid resuscitation until ICU discharge, death, or 90 days after randomization. The primary outcome was death within 90 days. Secondary outcomes included acute kidney injury and failure and treatment with renal-replacement therapy.

    Results: 
    A total of 597 of 3315 patients (18.0%) in the HES group and 566 of 3336 (17.0%) in the saline group died (relative risk in the HES group, 1.06; 95% confidence interval [CI], 0.96 to 1.18; P=0.26). There was no significant difference in mortality in six predefined subgroups. Renal-replacement therapy was used in 235 of 3352 patients (7.0%) in the HES group and 196 of 3375 (5.8%) in the saline group (relative risk, 1.21; 95% CI, 1.00 to 1.45; P=0.04). In the HES and saline groups, renal injury occurred in 34.6% and 38.0% of patients, respectively (P=0.005), and renal failure occurred in 10.4% and 9.2% of patients, respectively (P=0.12). HES was associated with significantly more adverse events (4.6% vs. 3.3%, P=0.006).

    Conclusions: In patients in the ICU, there was no significant difference in 90-day mortality between patients resuscitated with 6% HES (130/0.4) or saline. However, more patients who received resuscitation with HES were treated with renal-replacement therapy. (Funded by the National Health and Medical Research Council of Australia and others; CHEST ClinicalTrials.gov number, NCT00935168.)
    Original languageEnglish
    Pages (from-to)1901-1911
    Number of pages11
    JournalNew England Journal of Medicine
    Volume367
    Issue number20
    DOIs
    Publication statusPublished - 2012

    Fingerprint

    Critical Care
    Resuscitation
    Starch
    Renal Replacement Therapy
    Intensive Care Units
    Acute Kidney Injury
    Sodium Chloride
    Hydroxyethyl Starch Derivatives
    Confidence Intervals
    Kidney
    Mortality
    Random Allocation
    Renal Insufficiency
    Biomedical Research
    Molecular Weight
    Safety
    Survival
    Health
    Wounds and Injuries

    Cite this

    Myburgh, J., Finfer, S., Bellomo, R., Billot, L., Cass, A., Gattas, D., ... Webb, S. (2012). Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care. New England Journal of Medicine, 367(20), 1901-1911. https://doi.org/10.1056/NEJMoa1209759
    Myburgh, John ; Finfer, Simon ; Bellomo, Rinaldo ; Billot, Laurent ; Cass, Alan ; Gattas, David ; Glass, Parisa ; Lipman, Jeffrey ; Liu, Bette ; McArthur, Colin ; McGuinness, Shay ; Rajbhandari, Dorrilyn ; Taylor, Colman ; Webb, Steven. / Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care. In: New England Journal of Medicine. 2012 ; Vol. 367, No. 20. pp. 1901-1911.
    @article{e23a090146184d2b94040af3c4b43aaf,
    title = "Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care",
    abstract = "Background: The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have not been fully evaluated, and adverse effects of HES on survival and renal function have been reported.Methods: We randomly assigned 7000 patients who had been admitted to an intensive care unit (ICU) in a 1:1 ratio to receive either 6{\%} HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9{\%} sodium chloride or 0.9{\%} sodium chloride (saline) for all fluid resuscitation until ICU discharge, death, or 90 days after randomization. The primary outcome was death within 90 days. Secondary outcomes included acute kidney injury and failure and treatment with renal-replacement therapy.Results: A total of 597 of 3315 patients (18.0{\%}) in the HES group and 566 of 3336 (17.0{\%}) in the saline group died (relative risk in the HES group, 1.06; 95{\%} confidence interval [CI], 0.96 to 1.18; P=0.26). There was no significant difference in mortality in six predefined subgroups. Renal-replacement therapy was used in 235 of 3352 patients (7.0{\%}) in the HES group and 196 of 3375 (5.8{\%}) in the saline group (relative risk, 1.21; 95{\%} CI, 1.00 to 1.45; P=0.04). In the HES and saline groups, renal injury occurred in 34.6{\%} and 38.0{\%} of patients, respectively (P=0.005), and renal failure occurred in 10.4{\%} and 9.2{\%} of patients, respectively (P=0.12). HES was associated with significantly more adverse events (4.6{\%} vs. 3.3{\%}, P=0.006).Conclusions: In patients in the ICU, there was no significant difference in 90-day mortality between patients resuscitated with 6{\%} HES (130/0.4) or saline. However, more patients who received resuscitation with HES were treated with renal-replacement therapy. (Funded by the National Health and Medical Research Council of Australia and others; CHEST ClinicalTrials.gov number, NCT00935168.)",
    author = "John Myburgh and Simon Finfer and Rinaldo Bellomo and Laurent Billot and Alan Cass and David Gattas and Parisa Glass and Jeffrey Lipman and Bette Liu and Colin McArthur and Shay McGuinness and Dorrilyn Rajbhandari and Colman Taylor and Steven Webb",
    year = "2012",
    doi = "10.1056/NEJMoa1209759",
    language = "English",
    volume = "367",
    pages = "1901--1911",
    journal = "New England Journal of Medicine",
    issn = "0028-4793",
    publisher = "Massachusetts Medical Society",
    number = "20",

    }

    Myburgh, J, Finfer, S, Bellomo, R, Billot, L, Cass, A, Gattas, D, Glass, P, Lipman, J, Liu, B, McArthur, C, McGuinness, S, Rajbhandari, D, Taylor, C & Webb, S 2012, 'Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care', New England Journal of Medicine, vol. 367, no. 20, pp. 1901-1911. https://doi.org/10.1056/NEJMoa1209759

    Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care. / Myburgh, John; Finfer, Simon; Bellomo, Rinaldo; Billot, Laurent; Cass, Alan; Gattas, David; Glass, Parisa; Lipman, Jeffrey; Liu, Bette; McArthur, Colin; McGuinness, Shay; Rajbhandari, Dorrilyn; Taylor, Colman; Webb, Steven.

    In: New England Journal of Medicine, Vol. 367, No. 20, 2012, p. 1901-1911.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care

    AU - Myburgh, John

    AU - Finfer, Simon

    AU - Bellomo, Rinaldo

    AU - Billot, Laurent

    AU - Cass, Alan

    AU - Gattas, David

    AU - Glass, Parisa

    AU - Lipman, Jeffrey

    AU - Liu, Bette

    AU - McArthur, Colin

    AU - McGuinness, Shay

    AU - Rajbhandari, Dorrilyn

    AU - Taylor, Colman

    AU - Webb, Steven

    PY - 2012

    Y1 - 2012

    N2 - Background: The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have not been fully evaluated, and adverse effects of HES on survival and renal function have been reported.Methods: We randomly assigned 7000 patients who had been admitted to an intensive care unit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride or 0.9% sodium chloride (saline) for all fluid resuscitation until ICU discharge, death, or 90 days after randomization. The primary outcome was death within 90 days. Secondary outcomes included acute kidney injury and failure and treatment with renal-replacement therapy.Results: A total of 597 of 3315 patients (18.0%) in the HES group and 566 of 3336 (17.0%) in the saline group died (relative risk in the HES group, 1.06; 95% confidence interval [CI], 0.96 to 1.18; P=0.26). There was no significant difference in mortality in six predefined subgroups. Renal-replacement therapy was used in 235 of 3352 patients (7.0%) in the HES group and 196 of 3375 (5.8%) in the saline group (relative risk, 1.21; 95% CI, 1.00 to 1.45; P=0.04). In the HES and saline groups, renal injury occurred in 34.6% and 38.0% of patients, respectively (P=0.005), and renal failure occurred in 10.4% and 9.2% of patients, respectively (P=0.12). HES was associated with significantly more adverse events (4.6% vs. 3.3%, P=0.006).Conclusions: In patients in the ICU, there was no significant difference in 90-day mortality between patients resuscitated with 6% HES (130/0.4) or saline. However, more patients who received resuscitation with HES were treated with renal-replacement therapy. (Funded by the National Health and Medical Research Council of Australia and others; CHEST ClinicalTrials.gov number, NCT00935168.)

    AB - Background: The safety and efficacy of hydroxyethyl starch (HES) for fluid resuscitation have not been fully evaluated, and adverse effects of HES on survival and renal function have been reported.Methods: We randomly assigned 7000 patients who had been admitted to an intensive care unit (ICU) in a 1:1 ratio to receive either 6% HES with a molecular weight of 130 kD and a molar substitution ratio of 0.4 (130/0.4, Voluven) in 0.9% sodium chloride or 0.9% sodium chloride (saline) for all fluid resuscitation until ICU discharge, death, or 90 days after randomization. The primary outcome was death within 90 days. Secondary outcomes included acute kidney injury and failure and treatment with renal-replacement therapy.Results: A total of 597 of 3315 patients (18.0%) in the HES group and 566 of 3336 (17.0%) in the saline group died (relative risk in the HES group, 1.06; 95% confidence interval [CI], 0.96 to 1.18; P=0.26). There was no significant difference in mortality in six predefined subgroups. Renal-replacement therapy was used in 235 of 3352 patients (7.0%) in the HES group and 196 of 3375 (5.8%) in the saline group (relative risk, 1.21; 95% CI, 1.00 to 1.45; P=0.04). In the HES and saline groups, renal injury occurred in 34.6% and 38.0% of patients, respectively (P=0.005), and renal failure occurred in 10.4% and 9.2% of patients, respectively (P=0.12). HES was associated with significantly more adverse events (4.6% vs. 3.3%, P=0.006).Conclusions: In patients in the ICU, there was no significant difference in 90-day mortality between patients resuscitated with 6% HES (130/0.4) or saline. However, more patients who received resuscitation with HES were treated with renal-replacement therapy. (Funded by the National Health and Medical Research Council of Australia and others; CHEST ClinicalTrials.gov number, NCT00935168.)

    U2 - 10.1056/NEJMoa1209759

    DO - 10.1056/NEJMoa1209759

    M3 - Article

    VL - 367

    SP - 1901

    EP - 1911

    JO - New England Journal of Medicine

    JF - New England Journal of Medicine

    SN - 0028-4793

    IS - 20

    ER -