Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis

Area of Science:

• Critical Care Medicine
• Nephrology
• Pharmacology

Background:

• Hydroxyethyl starch (HES) is a common fluid resuscitation agent in intensive care units (ICUs).
• The safety and efficacy of HES in patients with severe sepsis remain uncertain.
• Severe sepsis poses significant risks, necessitating careful consideration of fluid resuscitation strategies.

Purpose of the Study:

• To compare the safety and efficacy of HES 130/0.42 versus Ringer's acetate for fluid resuscitation in patients with severe sepsis.
• To evaluate the primary outcome of death or end-stage kidney failure at 90 days post-randomization.
• To assess secondary outcomes including the need for renal-replacement therapy and severe bleeding events.

Main Methods:

• A multicenter, parallel-group, blinded trial was conducted.
• 804 patients with severe sepsis were randomized to receive either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate.
• Fluid resuscitation was administered up to 33 ml/kg/day, with outcomes assessed at 90 days.

Main Results:

• Patients receiving HES 130/0.42 showed a higher mortality rate at 90 days (51%) compared to Ringer's acetate (43%).
• The HES group required more renal-replacement therapy (22% vs. 16%) and experienced severe bleeding (10% vs. 6%).
• Multivariate analyses confirmed these findings, adjusting for baseline risk factors for death or acute kidney injury.

Conclusions:

• Fluid resuscitation with HES 130/0.42 in severe sepsis patients is associated with an increased risk of death and greater need for renal-replacement therapy.
• Ringer's acetate appears to be a safer alternative for fluid resuscitation in this patient population.
• The study provides critical evidence against the use of HES 130/0.42 in severe sepsis.