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Protocolised reduction of non-resuscitation fluids versus usual care in patients with septic shock (REDUSE) : a protocol for a multicentre feasibility trial

Lindén, Anja LU ; Fisher, Jane LU ; Lilja, Gisela LU ; Olsen, Markus Harboe ; Sjövall, Fredrik LU orcid ; Jungner, Mårten LU ; Spångfors, Martin LU orcid ; Samuelsson, Line ; Oras, Jonatan and Linder, Adam LU , et al. (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.

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organization
publishing date
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
  • pmid:36854601
  • scopus:85149153448
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
2024-06-13 18:07:00
@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}},
}