6S
Trial question
What is the role of hydroxyethyl starch 130/0.42 fluid resuscitation in patients with severe sepsis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
39.4% female
60.6% male
N = 804
804 patients (315 female, 483 male)
Inclusion criteria: ICU patients with severe sepsis
Key exclusion criteria: age < 18 years old, receipt of > 1,000 mL of synthetic colloid, RRT, acute burn injury > 10% body surface area, severe hyperkalemia, liver or kidney transplantation, intracranial bleeding
Interventions
N=398 HES 130/0.42 (6% hydroxyethyl starch 130/0.42, Tetraspan)
N=400 Ringer's lactate (at a dose of up to 33 mL/kg of ideal body weight per day)
Primary outcome
Death or end-stage kidney failure at 90 days
51
43
51.0 %
38.3 %
25.5 %
12.8 %
0.0 %
HES
130/0.42
Ringer's
lactate
Significant
increase ▲
NNH = 12
Significant increase in death or end-stage kidney failure at 90 days (51% vs. 43%; RR 1.17, 95% CI 1.01 to 1.36)
Secondary outcomes
No significant difference in death at day 28 (39% vs. 36%; RR 1.08, 95% CI 0.9 to 1.28)
No significant difference in severe bleeding (10% vs. 6%; RR 1.52, 95% CI 0.94 to 2.48)
No significant difference in RRT or renal SOFA score ≥ 3 (32% vs. 27%; RR 1.2, 95% CI 0.97 to 1.48)
Safety outcomes
No significant differences in severe allergic reaction, acidosis, doubling of plasma creatinine level.
Significant difference in use of RRT (22% vs. 16%).
Conclusion
In ICU patients with severe sepsis, HES 130/0.42 was inferior to Ringer's lactate with respect to death or end-stage kidney failure at 90 days.
Reference
Anders Perner, Nicolai Haase, Anne B Guttormsen et al. Hydroxyethyl starch 130 / 0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34.
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