Hydroxyethyl Starch or Saline for Fluid Resuscitation in Intensive Care
What is the safety and efficacy of hydroxyethyl starch (HES) compared with saline alone for fluid resuscitation in a heterogeneous population of adult patients treated in the intensive care unit (ICU)?
The investigators randomly assigned 7,000 patients who had been admitted to an 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. The authors compared survival times using log-rank tests and presented these as Kaplan–Meier curves.
A total of 597 of 3,315 patients (18.0%) in the HES group and 566 of 3,336 (17.0%) in the saline group died (relative risk in the HES group, 1.06; 95% confidence interval [CI], 0.96-1.18; p = 0.26). There was no significant difference in mortality in six predefined subgroups. Renal-replacement therapy was used in 235 of 3,352 patients (7.0%) in the HES group and 196 of 3,375 (5.8%) in the saline group (relative risk, 1.21; 95% CI, 1.00-1.45; 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 (5.3% vs. 2.8%, p < 0.001).
The authors concluded that there was no significant difference in 90-day mortality between patients resuscitated with 6% HES or saline.
In this randomized, controlled trial, there was no significant difference in mortality at 90 days in a heterogeneous population of ICU patients who received 6% HES (130/0.4) in 0.9% saline and those who received 0.9% saline alone for fluid resuscitation. In addition to the lack of apparent clinical benefit to the patient with HES, its use actually resulted in an increased rate of renal-replacement therapy. Overall, the data suggest that the selection of resuscitation fluid in critically ill patients requires careful consideration of its safety, its potential effect on clinical outcomes, and cost of such therapy.
Keywords: New Zealand, Resuscitation, Acute Kidney Injury, Hydroxyethyl Starch Derivatives, Renal Insufficiency, Sodium Chloride, Fluid Therapy, Heart Failure, Australia, Critical Illness, Confidence Intervals, Renal Replacement Therapy
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