Intensive Care Medicine

, Volume 40, Issue 7, pp 927–934

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

  • Anders Perner
  • Nicolai Haase
  • Per Winkel
  • Anne B. Guttormsen
  • Jyrki Tenhunen
  • Gudmundur Klemenzson
  • Rasmus G. Müller
  • Anders Åneman
  • Jørn Wetterslev
Seven-Day Profile Publication

DOI: 10.1007/s00134-014-3311-y

Cite this article as:
Perner, A., Haase, N., Winkel, P. et al. Intensive Care Med (2014) 40: 927. doi:10.1007/s00134-014-3311-y

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.

Keywords

Severe sepsis Fluid resuscitation Ringer’s acetate ICUs Hydroxyethyl starch 

Supplementary material

134_2014_3311_MOESM1_ESM.docx (27 kb)
Supplementary material 1 (DOCX 26 kb)

Copyright information

© Springer-Verlag Berlin Heidelberg and ESICM 2014

Authors and Affiliations

  • Anders Perner
    • 1
  • Nicolai Haase
    • 1
  • Per Winkel
    • 2
  • Anne B. Guttormsen
    • 3
    • 4
  • Jyrki Tenhunen
    • 5
    • 6
  • Gudmundur Klemenzson
    • 7
  • Rasmus G. Müller
    • 1
  • Anders Åneman
    • 8
  • Jørn Wetterslev
    • 2
  1. 1.Department of Intensive CareCopenhagen University Hospital, RigshospitaletCopenhagenDenmark
  2. 2.Copenhagen Trial Unit, Centre for Clinical Intervention ResearchCopenhagen University Hospital, RigshospitaletCopenhagenDenmark
  3. 3.Department of Anaesthesia and Intensive CareHaukeland University HospitalBergenNorway
  4. 4.Department of Clinical Medicine 1University of BergenBergenNorway
  5. 5.Critical Care Medicine Research Group in Department of Intensive Care MedicineTampere University HospitalTampereFinland
  6. 6.Department of Surgical Sciences/Anesthesiology and Intensive CareUppsala UniversityUppsalaSweden
  7. 7.Department of Anaesthesia and Intensive CareLandspitaliReykjavikIceland
  8. 8.Department of Intensive CareLiverpool HospitalSydneyAustralia

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