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Cited by 376Sepsis Diagnosis and TreatmentHemodynamic Monitoring and TherapyAbdominal Surgery and Complications

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

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The CLASSIC Trial Group, Hjortrup, Peter B., The Scandinavian Critical Care Trials Group, Haase, Nicolai, Bundgaard, Helle, Thomsen, Simon L., Winding, Robert, Pettilä, Ville +8 more·2016·Intensive Care Medicine
DOI 10.1007/s00134-016-4500-7
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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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  • The current evidence evaluating a restrictive IV fluid strategy in septic patients varies in inclusion criteria, definitions of restrictive and liberal strategies, criteria for additional fluids, and duration of interventions.

    “The current evidence evaluating a restrictive IV fluid strategy in the management of septic patients varies with respect to the inclusion criteria, the definition of restrictive and liberal fluid strategies, the criteria guiding the administration of additional IV fluids (e.g., perfusion parameters vs. haemodynamic variables), and the duration of the interventions [397–401].”

    From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [399]

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Authors
The CLASSIC Trial Group, Hjortrup, P. B., The Scandinavian Critical Care Trials Group, Haase, N., Bundgaard, H., Thomsen, S. L., Winding, R., Pettilä, V., Aaen, A., Lodahl, D., Berthelsen, R. E., Christensen, H., Madsen, M. B., Winkel, P., Wetterslev, J., & Perner, A.
Affiliations
  • Copenhagen University Hospital (DK)
  • Regional Hospital Randers (DK)
  • Aalborg University Hospital (DK)
  • Regionshospitalet Herning (DK)
  • Helsinki University Hospital (FI)
  • Nordsjællands Hospital (DK)
  • Herlev Hospital (DK)
Corresponding author
Perner, Anders
ORCID
Venue
Intensive Care Medicine
Publisher
Springer Science and Business Media LLC
Published
2016-09-30
Volume
42
Issue
11
Pages
1695-1705
ISSN
  • 0342-4642 (ISSN-L)
  • 1432-1238
DOI
10.1007/s00134-016-4500-7
OpenAlex
W2508264804
Cited by
376
References
28
Citations by year
2026: 12 · 2025: 15 · 2024: 32 · 2023: 49 · 2022: 49 · 2021: 42 · 2020: 50 · 2019: 49 · 2018: 41 · 2017: 34 · 2016: 3
FWCI
39.74
Type
journal article
Language
en
Open access
Licence
Locations
  • Intensive Care Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Työväentutkimus Vuosikirja (submittedVersion, other-oa)
  • Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
  • VBN Forskningsportal (Aalborg Universitet) (submittedVersion)
Funders
Strategiske Forskningsråd (09-066938)
Topics
  • Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
  • Health Sciences › Medicine › Surgery › Hemodynamic Monitoring and Therapy
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Abdominal Surgery and Complications
Keywords
septic shock, fluid restriction, fluid resuscitation, intensive care unit, hypoperfusion, acute kidney injury, ischemic events, mortality, protocol adherence, sepsis treatment
MeSH terms
Aged, Blood Circulation, Critical Care, Feasibility Studies, Female, Fluid Therapy, Humans, Intensive Care Units, Male, Middle Aged, Resuscitation, Shock, Septic, Water-Electrolyte Balance, Odds Ratio

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