Protocolized REDUction of Non-Resuscitation Fluids in SEptic Shock Patients. A Protocol for the REDUSE Randomized Clinical Trial
(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.
(Less)
- author
- organization
-
- Anaesthesiology and Intensive Care Medicine (research group)
- Fluid resuscitation in critical illness (research group)
- Anesthesiology and Intensive Care
- Brain Injury After Cardiac Arrest (research group)
- Center for cardiac arrest (research group)
- Neurology, Lund
- Mitochondrial Medicine (research group)
- Clinical Research in Anaesthesia and Intensive Care Medicine (research group)
- Heparin bindning protein in cardiothoracic surgery (research group)
- SEBRA Sepsis and Bacterial Resistance Alliance (research group)
- Translational Sepsis research (research group)
- publishing date
- 2025-08
- 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
- 2025-07-31 14:42:31
@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}}, }