Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis

Anders Perner; Nicolai Haase; Anne B Guttormsen; Jyrki Tenhunen; Gudmundur Klemenzson; Anders Åneman; Kristian R Madsen; Morten H Møller; Jeanie M Elkjær; Lone M Poulsen; Asger Bendtsen; Robert Winding; Morten Steensen; Pawel Berezowicz; Peter Søe-Jensen; Morten Bestle; Kristian Strand; Jørgen Wiis; Jonathan O White; Klaus J Thornberg; Lars Quist; Jonas Nielsen; Lasse H Andersen; Lars B Holst; Katrin Thormar; Anne-Lene Kjældgaard; Maria L Fabritius; Frederik Mondrup; Frank C Pott; Thea P Møller; Per Winkel; Jørn Wetterslev; 6S Trial Group

doi:10.1056/nejmoa1204242

Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis

Anders Perner, Nicolai Haase, Anne B Guttormsen, Jyrki Tenhunen, Gudmundur Klemenzson, Anders Åneman, Kristian R Madsen, Morten H Møller, Jeanie M Elkjær, Lone M Poulsen, Asger Bendtsen, Robert Winding, Morten Steensen, Pawel Berezowicz, Peter Søe-Jensen, Morten Bestle, Kristian Strand, Jørgen Wiis, Jonathan O White, Klaus J ThornbergLars Quist, Jonas Nielsen, Lasse H Andersen, Lars B Holst, Katrin Thormar, Anne-Lene Kjældgaard, Maria L Fabritius, Frederik Mondrup, Frank C Pott, Thea P Møller, Per Winkel, Jørn Wetterslev, 6S Trial Group

1231 Citationer (Scopus)

Abstract

BACKGROUND: Hydroxyethyl starch (HES) 130/0.42 is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis. METHODS: In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization. RESULTS Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P = 0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 1.80; P = 0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P = 0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline. CONCLUSIONS: Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer's acetate. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.)

Originalsprog	Engelsk
Tidsskrift	New England Journal of Medicine
Vol/bind	367
Udgave nummer	2
Sider (fra-til)	124-34
Antal sider	11
ISSN	0028-4793
DOI	https://doi.org/10.1056/nejmoa1204242
Status	Udgivet - 12 jul. 2012

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10.1056/nejmoa1204242

https://www.nejm.org/doi/pdf/10.1056/NEJMoa1204242?articleTools=true

Citationsformater

Perner, A., Haase, N., Guttormsen, A. B., Tenhunen, J., Klemenzson, G., Åneman, A., Madsen, K. R., Møller, M. H., Elkjær, J. M., Poulsen, L. M., Bendtsen, A., Winding, R., Steensen, M., Berezowicz, P., Søe-Jensen, P., Bestle, M., Strand, K., Wiis, J., White, J. O., ... 6S Trial Group (2012). Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. New England Journal of Medicine, 367(2), 124-34. https://doi.org/10.1056/nejmoa1204242

Perner, A, Haase, N, Guttormsen, AB, Tenhunen, J, Klemenzson, G, Åneman, A, Madsen, KR, Møller, MH, Elkjær, JM, Poulsen, LM, Bendtsen, A, Winding, R, Steensen, M, Berezowicz, P, Søe-Jensen, P, Bestle, M, Strand, K, Wiis, J, White, JO, Thornberg, KJ, Quist, L, Nielsen, J, Andersen, LH, Holst, LB, Thormar, K, Kjældgaard, A-L, Fabritius, ML, Mondrup, F, Pott, FC, Møller, TP, Winkel, P, Wetterslev, J & 6S Trial Group 2012, 'Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis', New England Journal of Medicine, bind 367, nr. 2, s. 124-34. https://doi.org/10.1056/nejmoa1204242

@article{a78d029dceaf45c2999e9b996a9d71fa,

title = "Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis",

abstract = "BACKGROUND: Hydroxyethyl starch (HES) 130/0.42 is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis. METHODS: In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization. RESULTS Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P = 0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 1.80; P = 0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P = 0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline. CONCLUSIONS: Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer's acetate. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.)",

author = "Anders Perner and Nicolai Haase and Guttormsen, {Anne B} and Jyrki Tenhunen and Gudmundur Klemenzson and Anders {\AA}neman and Madsen, {Kristian R} and M{\o}ller, {Morten H} and Elkj{\ae}r, {Jeanie M} and Poulsen, {Lone M} and Asger Bendtsen and Robert Winding and Morten Steensen and Pawel Berezowicz and Peter S{\o}e-Jensen and Morten Bestle and Kristian Strand and J{\o}rgen Wiis and White, {Jonathan O} and Thornberg, {Klaus J} and Lars Quist and Jonas Nielsen and Andersen, {Lasse H} and Holst, {Lars B} and Katrin Thormar and Anne-Lene Kj{\ae}ldgaard and Fabritius, {Maria L} and Frederik Mondrup and Pott, {Frank C} and M{\o}ller, {Thea P} and Per Winkel and J{\o}rn Wetterslev and Pott, {Frank Christian}",

year = "2012",

month = jul,

day = "12",

doi = "10.1056/nejmoa1204242",

language = "English",

volume = "367",

pages = "124--34",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "2",

}

TY - JOUR

T1 - Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis

AU - Perner, Anders

AU - Haase, Nicolai

AU - Guttormsen, Anne B

AU - Tenhunen, Jyrki

AU - Klemenzson, Gudmundur

AU - Åneman, Anders

AU - Madsen, Kristian R

AU - Møller, Morten H

AU - Elkjær, Jeanie M

AU - Poulsen, Lone M

AU - Bendtsen, Asger

AU - Winding, Robert

AU - Steensen, Morten

AU - Berezowicz, Pawel

AU - Søe-Jensen, Peter

AU - Bestle, Morten

AU - Strand, Kristian

AU - Wiis, Jørgen

AU - White, Jonathan O

AU - Thornberg, Klaus J

AU - Quist, Lars

AU - Nielsen, Jonas

AU - Andersen, Lasse H

AU - Holst, Lars B

AU - Thormar, Katrin

AU - Kjældgaard, Anne-Lene

AU - Fabritius, Maria L

AU - Mondrup, Frederik

AU - Pott, Frank C

AU - Møller, Thea P

AU - Winkel, Per

AU - Wetterslev, Jørn

AU - 6S Trial Group

PY - 2012/7/12

Y1 - 2012/7/12

N2 - BACKGROUND: Hydroxyethyl starch (HES) 130/0.42 is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis. METHODS: In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization. RESULTS Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P = 0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 1.80; P = 0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P = 0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline. CONCLUSIONS: Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer's acetate. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.)

AB - BACKGROUND: Hydroxyethyl starch (HES) 130/0.42 is widely used for fluid resuscitation in intensive care units (ICUs), but its safety and efficacy have not been established in patients with severe sepsis. METHODS: In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42 (Tetraspan) or Ringer's acetate at a dose of up to 33 ml per kilogram of ideal body weight per day. The primary outcome measure was either death or end-stage kidney failure (dependence on dialysis) at 90 days after randomization. RESULTS Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to Ringer's acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36; P = 0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period, 87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer's acetate (relative risk, 1.35; 95% CI, 1.01 to 1.80; P = 0.04), and 38 patients (10%) and 25 patients (6%), respectively, had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P = 0.09). The results were supported by multivariate analyses, with adjustment for known risk factors for death or acute kidney injury at baseline. CONCLUSIONS: Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer's acetate. (Funded by the Danish Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.)

U2 - 10.1056/nejmoa1204242

DO - 10.1056/nejmoa1204242

M3 - Journal article

C2 - 22738085

SN - 0028-4793

VL - 367

SP - 124

EP - 134

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 2

ER -

Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis

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