6S Trial

NEJM

July 12, 2012

Hydroxyethyl Starch 130/0.42 versus Ringer's Acetate in Severe Sepsis.

What was the research question?

  • What is the safety and efficacy of 6% HES (130/0.4) as compared with Ringer's acetate for fluid resuscitation in patients with severe sepsis?


How did they do it?

  • A multicenter, parallel-group, blinded trial in 26 ICUs in Denmark, Norway, Finland, and Iceland.

  • 804 patients with severe sepsis were randomized to receive either 6% HES 130/0.42 or Ringer's acetate for to fluid resuscitation in the ICU.

  • The primary outcome was a composite of either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization.


What did they find?

  • Composite outcome of 90-day mortality rate or dependence on dialysis was more common with HES group than Ringer’s acetate group (51% versus 43%; P= 0.03) but mainly driven by mortality (only one patient dependent on HD in each group).

  • 90-day mortality rate was significantly higher in the HES group compared to the Ringer’s acetate group (51% versus 43%; P= 0.03, NNH 13).

  • There was no difference in 28-day mortality between the HES group and the Ringer’s acetate group (39% vs. 36%, P=0.43).

  • Renal replacement therapy was significantly higher in the HES group compared to the Ringer’s group (22% vs. 16%; P=0.04, NNH 17).

  • Severe bleeding was not significantly different between the two groups (10% vs. 6%; P=0.09).


What does it mean?

· Fluid resuscitation with HES 130/0.42 in patients with severe sepsis is associated with an increased risk of death at day 90 and higher likelihood to require renal-replacement therapy, as compared with those receiving Ringer's acetate.

· HES should not be used in the ICU for resuscitation od septic patients

6S Trial