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Erschienen in: Intensive Care Medicine 11/2016

30.09.2016 | Seven-Day Profile Publication

Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial

verfasst von: Peter B. Hjortrup, Nicolai Haase, Helle Bundgaard, Simon L. Thomsen, Robert Winding, Ville Pettilä, Anne Aaen, David Lodahl, Rasmus E. Berthelsen, Henrik Christensen, Martin B. Madsen, Per Winkel, Jørn Wetterslev, Anders Perner, The CLASSIC Trial Group, The Scandinavian Critical Care Trials Group

Erschienen in: Intensive Care Medicine | Ausgabe 11/2016

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Abstract

Purpose

We assessed the effects of a protocol restricting resuscitation fluid vs. a standard care protocol after initial resuscitation in intensive care unit (ICU) patients with septic shock.

Methods

We randomised 151 adult patients with septic shock who had received initial fluid resuscitation in nine Scandinavian ICUs. In the fluid restriction group fluid boluses were permitted only if signs of severe hypoperfusion occurred, while in the standard care group fluid boluses were permitted as long as circulation continued to improve.

Results

The co-primary outcome measures, resuscitation fluid volumes at day 5 and during ICU stay, were lower in the fluid restriction group than in the standard care group [mean differences −1.2 L (95 % confidence interval −2.0 to −0.4); p < 0.001 and −1.4 L (−2.4 to −0.4) respectively; p < 0.001]. Neither total fluid inputs and balances nor serious adverse reactions differed statistically significantly between the groups. Major protocol violations occurred in 27/75 patients in the fluid restriction group. Ischaemic events occurred in 3/75 in the fluid restriction group vs. 9/76 in the standard care group (odds ratio 0.32; 0.08–1.27; p = 0.11), worsening of acute kidney injury in 27/73 vs. 39/72 (0.46; 0.23–0.92; p = 0.03), and death by 90 days in 25/75 vs. 31/76 (0.71; 0.36–1.40; p = 0.32).

Conclusions

A protocol restricting resuscitation fluid successfully reduced volumes of resuscitation fluid compared with a standard care protocol in adult ICU patients with septic shock. The patient-centred outcomes all pointed towards benefit with fluid restriction, but our trial was not powered to show differences in these exploratory outcomes.

Trial registration

NCT02079402.
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Metadaten
Titel
Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial
verfasst von
Peter B. Hjortrup
Nicolai Haase
Helle Bundgaard
Simon L. Thomsen
Robert Winding
Ville Pettilä
Anne Aaen
David Lodahl
Rasmus E. Berthelsen
Henrik Christensen
Martin B. Madsen
Per Winkel
Jørn Wetterslev
Anders Perner
The CLASSIC Trial Group
The Scandinavian Critical Care Trials Group
Publikationsdatum
30.09.2016
Verlag
Springer Berlin Heidelberg
Erschienen in
Intensive Care Medicine / Ausgabe 11/2016
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-016-4500-7

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