Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer’s acetate
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We assessed long-term mortality and hospitalisation in patients with severe sepsis resuscitated with hydroxyethyl starch (HES) or Ringer’s acetate.
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.
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).
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.
KeywordsSevere sepsis Fluid resuscitation Ringer’s acetate ICUs Hydroxyethyl starch
Conflicts of interest
All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: The 6S trial was funded by the Danish Medical Research Council (271-08-0691 and 09-066938) and supported by Rigshospitalets Research Council and the Scandinavian Society of Anaesthesiology and Intensive Care Medicine (the ACTA foundation) and endorsed by the European Clinical Research Infrastructures Network (ECRIN). B Braun AG delivered trial fluids to all trial sites free of charges. Neither the funding organisations nor B Braun had any influence on (1) the design and conduct of the study; (2) the collection, management, analysis and interpretation of the data; (3) the preparation, review or approval of the manuscript; (4) the decision to submit the manuscript for publication. AP is head of research in his ICU, which receives research funds from CSL Behring, Switzerland, Fresenius Kabi, Germany, COSMED, Italy and Bioporto Diagnostics A/S, Denmark and has received a speaker’s fee from LFP SA, France. B Braun AG has covered his travel expenses for presenting 6S-data at the German Anaesthetic Congress 2012.
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