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Protocolized REDUction of Non-Resuscitation Fluids in SEptic Shock Patients. A Protocol for the REDUSE Randomized Clinical Trial

Bentzer, Peter LU ; Lindén, Anja LU ; Olsen, Markus H. ; Lilja, Gisela LU ; Fisher, Jane LU ; Sjövall, Fredrik LU orcid ; Kander, Thomas LU orcid ; Lengquist, Maria LU orcid ; Samuelsson, Line and Undén, Johan LU , et al. (2025) In Acta Anaesthesiologica Scandinavica 69(7).
Abstract

In septic shock, administration of large fluid volumes is associated with poor outcomes. Recent evidence shows that non-resuscitation fluids are the major modifiable source of fluids for patients with septic shock in intensive care units (ICUs). This clinical trial is designed to test the hypothesis that restrictive administration of non-resuscitation fluids improves outcomes compared to usual care. Adult patients admitted to ICUs with septic shock will be randomly assigned within 12 h of admission to receive protocolized restrictive administration of non-resuscitation fluids or usual care. The primary outcome is all-cause mortality at 90 days. Secondary outcomes are complications during ICU stay up to 90 days (defined as any acute... (More)

In septic shock, administration of large fluid volumes is associated with poor outcomes. Recent evidence shows that non-resuscitation fluids are the major modifiable source of fluids for patients with septic shock in intensive care units (ICUs). This clinical trial is designed to test the hypothesis that restrictive administration of non-resuscitation fluids improves outcomes compared to usual care. Adult patients admitted to ICUs with septic shock will be randomly assigned within 12 h of admission to receive protocolized restrictive administration of non-resuscitation fluids or usual care. The primary outcome is all-cause mortality at 90 days. Secondary outcomes are complications during ICU stay up to 90 days (defined as any acute kidney injury or cerebral, coronary, intestinal, or limb ischemia), mechanical ventilation free days within 90 days, and for survivors cognitive function (by the Montreal Cognitive Assessment [MOCA-BLIND]) and Health-Related Quality of Life (by the EQ Visual Analogue Scale [EQ-VAS]), both at 6 months. In addition, the climate impact of the interventions will be assessed. To detect an absolute reduction in mortality of 7.5%, with an alpha of 5% and a power of 90%, we aim to include 1850 patients. The trial is approved by the Swedish Ethical Review Authority. Results of primary and secondary clinical outcomes and the environmental outcome will be submitted for publication in a peer-reviewed journal. Trial Registration: NCT06140147.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Acta Anaesthesiologica Scandinavica
volume
69
issue
7
article number
e70095
publisher
Blackwell Munksgaard
external identifiers
  • pmid:40671283
  • scopus:105011100273
ISSN
0001-5172
DOI
10.1111/aas.70095
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2025 The Author(s). Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.
id
e548a410-7def-4c0e-9001-d894ae88cc4c
date added to LUP
2025-07-29 04:01:02
date last changed
2025-08-12 05:52:23
@article{e548a410-7def-4c0e-9001-d894ae88cc4c,
  abstract     = {{<p>In septic shock, administration of large fluid volumes is associated with poor outcomes. Recent evidence shows that non-resuscitation fluids are the major modifiable source of fluids for patients with septic shock in intensive care units (ICUs). This clinical trial is designed to test the hypothesis that restrictive administration of non-resuscitation fluids improves outcomes compared to usual care. Adult patients admitted to ICUs with septic shock will be randomly assigned within 12 h of admission to receive protocolized restrictive administration of non-resuscitation fluids or usual care. The primary outcome is all-cause mortality at 90 days. Secondary outcomes are complications during ICU stay up to 90 days (defined as any acute kidney injury or cerebral, coronary, intestinal, or limb ischemia), mechanical ventilation free days within 90 days, and for survivors cognitive function (by the Montreal Cognitive Assessment [MOCA-BLIND]) and Health-Related Quality of Life (by the EQ Visual Analogue Scale [EQ-VAS]), both at 6 months. In addition, the climate impact of the interventions will be assessed. To detect an absolute reduction in mortality of 7.5%, with an alpha of 5% and a power of 90%, we aim to include 1850 patients. The trial is approved by the Swedish Ethical Review Authority. Results of primary and secondary clinical outcomes and the environmental outcome will be submitted for publication in a peer-reviewed journal. Trial Registration: NCT06140147.</p>}},
  author       = {{Bentzer, Peter and Lindén, Anja and Olsen, Markus H. and Lilja, Gisela and Fisher, Jane and Sjövall, Fredrik and Kander, Thomas and Lengquist, Maria and Samuelsson, Line and Undén, Johan and Palmnäs, Ewa and Oras, Jonatan and Cronhjort, Maria and Balintescu, Anca and Lind, Alicia and Ahlström, Björn and Meirik, Maria and Savilampi, Johanna and Pekkarinen, Pirkka and Berggren, Anna and Oscarsson, Nicklas and Said, Mohammed and Castegren, Markus and Faria, Susanne and Hemberg, Linn and Linder, Adam and Lipcsey, Miklos and Skrifvars, Marcus B. and Wise, Matt P. and Nielsen, Niklas and Jakobsen, Janus C.}},
  issn         = {{0001-5172}},
  language     = {{eng}},
  number       = {{7}},
  publisher    = {{Blackwell Munksgaard}},
  series       = {{Acta Anaesthesiologica Scandinavica}},
  title        = {{Protocolized REDUction of Non-Resuscitation Fluids in SEptic Shock Patients. A Protocol for the REDUSE Randomized Clinical Trial}},
  url          = {{http://dx.doi.org/10.1111/aas.70095}},
  doi          = {{10.1111/aas.70095}},
  volume       = {{69}},
  year         = {{2025}},
}