Protocolised reduction of non-resuscitation fluids versus usual care in patients with septic shock (REDUSE) : a protocol for a multicentre feasibility trial
(2023) In BMJ Open 13(2). p.1-8- Abstract
INTRODUCTION: Administration of large volumes of fluids is associated with poor outcome in septic shock. Recent data suggest that non-resuscitation fluids are the major source of fluids in the intensive care unit (ICU) patients suffering from septic shock. The present trial is designed to test the hypothesis that a protocol targeting this source of fluids can reduce fluid administration compared with usual care. METHODS AND ANALYSIS: The design will be a multicentre, randomised, feasibility trial. Adult patients admitted to ICUs with septic shock will be randomised within 12 hours of admission to receive non-resuscitation fluids either according to a restrictive protocol or to receive usual care. The healthcare providers involved in the... (More)
INTRODUCTION: Administration of large volumes of fluids is associated with poor outcome in septic shock. Recent data suggest that non-resuscitation fluids are the major source of fluids in the intensive care unit (ICU) patients suffering from septic shock. The present trial is designed to test the hypothesis that a protocol targeting this source of fluids can reduce fluid administration compared with usual care. METHODS AND ANALYSIS: The design will be a multicentre, randomised, feasibility trial. Adult patients admitted to ICUs with septic shock will be randomised within 12 hours of admission to receive non-resuscitation fluids either according to a restrictive protocol or to receive usual care. The healthcare providers involved in the care of participants will not be blinded. The participants, outcome assessors at the 6-month follow-up and statisticians will be blinded. Primary outcome will be litres of fluids administered within 3 days of randomisation. Secondary outcomes will be proportion of randomised participants with outcome data on all-cause mortality; days alive and free of mechanical ventilation within 90 days of inclusion; any acute kidney injury and ischaemic events in the ICU (cerebral, cardiac, intestinal or limb ischaemia); proportion of surviving randomised patients who were assessed by European Quality of Life 5-Dimensions 5-Level questionnaire and Montreal Cognitive Assessment; proportion of all eligible patients who were randomised and proportion of participants experiencing at least one protocol violation. ETHICS AND DISSEMINATION: Ethics approval has been obtained in Sweden. Results of the primary and secondary outcomes will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05249088.
(Less)
- author
- organization
-
- Anesthesiology and Intensive Care
- Brain Injury After Cardiac Arrest (research group)
- Center for cardiac arrest (research group)
- Mitochondrial Medicine (research group)
- Fluid resuscitation in critical illness (research group)
- SEBRA Sepsis and Bacterial Resistance Alliance (research group)
- Translational Sepsis research (research group)
- Heparin bindning protein in cardiothoracic surgery (research group)
- Clinical Research in Anaesthesia and Intensive Care Medicine (research group)
- publishing date
- 2023-02-28
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- adult intensive & critical care, infectious diseases
- in
- BMJ Open
- volume
- 13
- issue
- 2
- article number
- e065392
- pages
- 1 - 8
- publisher
- BMJ Publishing Group
- external identifiers
-
- scopus:85149153448
- pmid:36854601
- ISSN
- 2044-6055
- DOI
- 10.1136/bmjopen-2022-065392
- language
- English
- LU publication?
- yes
- additional info
- Publisher Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
- id
- a899b3f5-bc39-4f1d-81e0-87fa95c58b86
- date added to LUP
- 2023-03-10 06:56:38
- date last changed
- 2024-09-20 03:18:26
@article{a899b3f5-bc39-4f1d-81e0-87fa95c58b86, abstract = {{<p>INTRODUCTION: Administration of large volumes of fluids is associated with poor outcome in septic shock. Recent data suggest that non-resuscitation fluids are the major source of fluids in the intensive care unit (ICU) patients suffering from septic shock. The present trial is designed to test the hypothesis that a protocol targeting this source of fluids can reduce fluid administration compared with usual care. METHODS AND ANALYSIS: The design will be a multicentre, randomised, feasibility trial. Adult patients admitted to ICUs with septic shock will be randomised within 12 hours of admission to receive non-resuscitation fluids either according to a restrictive protocol or to receive usual care. The healthcare providers involved in the care of participants will not be blinded. The participants, outcome assessors at the 6-month follow-up and statisticians will be blinded. Primary outcome will be litres of fluids administered within 3 days of randomisation. Secondary outcomes will be proportion of randomised participants with outcome data on all-cause mortality; days alive and free of mechanical ventilation within 90 days of inclusion; any acute kidney injury and ischaemic events in the ICU (cerebral, cardiac, intestinal or limb ischaemia); proportion of surviving randomised patients who were assessed by European Quality of Life 5-Dimensions 5-Level questionnaire and Montreal Cognitive Assessment; proportion of all eligible patients who were randomised and proportion of participants experiencing at least one protocol violation. ETHICS AND DISSEMINATION: Ethics approval has been obtained in Sweden. Results of the primary and secondary outcomes will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05249088.</p>}}, author = {{Lindén, Anja and Fisher, Jane and Lilja, Gisela and Olsen, Markus Harboe and Sjövall, Fredrik and Jungner, Mårten and Spångfors, Martin and Samuelsson, Line and Oras, Jonatan and Linder, Adam and Unden, Johan and Kander, T. and Lipcsey, Miklós and Nielsen, Niklas and Jakobsen, Janus C. and Bentzer, Peter}}, issn = {{2044-6055}}, keywords = {{adult intensive & critical care; infectious diseases}}, language = {{eng}}, month = {{02}}, number = {{2}}, pages = {{1--8}}, publisher = {{BMJ Publishing Group}}, series = {{BMJ Open}}, title = {{Protocolised reduction of non-resuscitation fluids versus usual care in patients with septic shock (REDUSE) : a protocol for a multicentre feasibility trial}}, url = {{http://dx.doi.org/10.1136/bmjopen-2022-065392}}, doi = {{10.1136/bmjopen-2022-065392}}, volume = {{13}}, year = {{2023}}, }