, Volume 40, Issue 7, pp 927-934
Date: 08 May 2014

Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer’s acetate

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access

Abstract

Purpose

We assessed long-term mortality and hospitalisation in patients with severe sepsis resuscitated with hydroxyethyl starch (HES) or Ringer’s acetate.

Methods

This was an investigator-initiated, parallel-grouped, blinded randomised trial using computer-generated allocation sequence and centralised allocation data that included 804 patients with severe sepsis needing fluid resuscitation in 26 general intensive care units (ICUs) in Scandinavia. Patients were allocated to fluid resuscitation using either 6 % HES 130/0.42 or Ringer’s acetate during ICU admission. We assessed mortality rates at 6 months, 1 year and at the time of longest follow-up and days alive and out of hospital at 1 year.

Results

The vital status of all patients was obtained at a median of 22 (range 13–36) months after randomisation. Mortality rates in the HES versus Ringer’s groups at 6 months were 53.3 (212/398 patients) versus 47.5 % (190/400) [relative risk 1.12; 95 % confidence interval (CI) 0.98–1.29; P = 0.10], respectively; at 1 year, 56.0 (223/398) versus 51.5 % (206/400) (1.09; 95 % CI 0.96–1.24; P = 0.20), respectively; at the time of longest follow-up, 59.8 (238/398) versus 56.3 % (225/400) (1.06; 95 % CI 0.94–1.20; P = 0.31), respectively. Percentage of days alive and out of hospital at 1 year in the HES versus Ringer’s groups was 24 (0–87 days) versus 63 % (0–90) (P = 0.07).

Conclusions

The long-term mortality rates did not differ in patients with severe sepsis assigned to HES 130/0.42 versus Ringer’s acetate, but we could not reject a 24 % relative increased or a 4 % relative decreased mortality at 1 year with HES at the 95 % confidence level.

Take-home message:

The long-term mortality rates did not differ in patients with severe sepsis assigned to HES 130/0.42 versus Ringer’s acetate, but the trial was not powered to show this. As 90-day mortality differed, the data indicate that the harmful effects of HES occurred within the first months after randomisation.
On behalf of the 6S trial group, and the Scandinavian Critical Care Trials Group.
Members of the Scandinavian Starch for Severe Sepsis/Septic Shock (6S) trial group are listed in the Appendix.
Trial registration: clinicaltrials.gov NCT00962156.