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

TY - JOUR

T1 - Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer’s acetate

AU - Perner, Anders

AU - Haase, Nicolai

AU - Winkel, Per

AU - Guttormsen, Anne B

AU - Tenhunen, Jyrki

AU - Klemenzson, Gudmundur

AU - Müller, Rasmus G

AU - Aneman, Anders

AU - Wetterslev, Jørn

PY - 2014/4

Y1 - 2014/4

N2 - 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.

AB - 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.

KW - Aged

KW - Double-Blind Method

KW - Female

KW - Fluid Therapy

KW - Follow-Up Studies

KW - Hospitalization

KW - Humans

KW - Hydroxyethyl Starch Derivatives

KW - Intensive Care Units

KW - Isotonic Solutions

KW - Male

KW - Middle Aged

KW - Patient Readmission

KW - Resuscitation

KW - Scandinavian and Nordic Countries

KW - Sepsis

KW - Severity of Illness Index

U2 - 10.1007/s00134-014-3311-y

DO - 10.1007/s00134-014-3311-y

M3 - Journal article

C2 - 24807084

SN - 0935-1701

VL - 40

SP - 927

EP - 934

JO - European Journal of Intensive Care Medicine

JF - European Journal of Intensive Care Medicine

IS - 7

ER -