Protocolized reduction of non-resuscitation fluids versus usual care in septic shock patients (REDUSE) : a randomized multicentre feasibility trial
Lindén, Anja LU ; Spångfors, M LU
; Olsen, M H
; Fisher, J
LU
; Lilja, G
LU
; Sjövall, F
LU
; Jungner, M
LU
; Lengquist, M
LU
; Kander, T
LU
and Samuelsson, L
, et al.
(2024)
In Critical care (London, England)
28(1).
- Abstract
BACKGROUND/PURPOSE: Non-resuscitation fluids constitute the majority of fluid administered for septic shock patients in the intensive care unit (ICU). This multicentre, randomized, feasibility trial was conducted to test the hypothesis that a restrictive protocol targeting non-resuscitation fluids reduces the overall volume administered compared with usual care.
METHODS: Adults with septic shock in six Swedish ICUs were randomized within 12 h of ICU admission to receive either protocolized reduction of non-resuscitation fluids or usual care. The primary outcome was the total volume of fluid administered within three days of inclusion.
RESULTS: Median (IQR) total volume of fluid in the first three days, was 6008 ml... (More)
BACKGROUND/PURPOSE: Non-resuscitation fluids constitute the majority of fluid administered for septic shock patients in the intensive care unit (ICU). This multicentre, randomized, feasibility trial was conducted to test the hypothesis that a restrictive protocol targeting non-resuscitation fluids reduces the overall volume administered compared with usual care.
METHODS: Adults with septic shock in six Swedish ICUs were randomized within 12 h of ICU admission to receive either protocolized reduction of non-resuscitation fluids or usual care. The primary outcome was the total volume of fluid administered within three days of inclusion.
RESULTS: Median (IQR) total volume of fluid in the first three days, was 6008 ml (interquartile range [IQR] 3960-8123) in the restrictive fluid group (n = 44), and 9765 ml (IQR 6804-12,401) in the control group (n = 48); corresponding to a Hodges-Lehmann median difference of 3560 ml [95% confidence interval 1614-5302]; p < 0.001). Outcome data on all-cause mortality, days alive and free of mechanical ventilation and acute kidney injury or ischemic events in the ICU within 90 days of inclusion were recorded in 98/98 (100%), 95/98 (98%) and 95/98 (98%) of participants respectively. Cognition and health-related quality of life at six months were recorded in 39/52 (75%) and 41/52 (79%) of surviving participants, respectively. Ninety out of 134 patients (67%) of eligible patients were randomized, and 15/98 (15%) of the participants experienced at least one protocol violation.
CONCLUSION: Protocolized reduction of non-resuscitation fluids in patients with septic shock resulted in a large decrease in fluid administration compared with usual care. A trial using this design to test if reducing non-resuscitation fluids improves outcomes is feasible.
TRIAL REGISTRATION: Clinicaltrials.gov, NCT05249088, 18 February 2022. https://clinicaltrials.gov/ct2/show/NCT05249088.
(Less)
- author
- Lindén, Anja
LU
; Spångfors, M
LU
; Olsen, M H
; Fisher, J
LU
; Lilja, G
LU
; Sjövall, F
LU
; Jungner, M
LU
; Lengquist, M
LU
; Kander, T
LU
and Samuelsson, L
, et al. (More)
- Lindén, Anja
LU
; Spångfors, M
LU
; Olsen, M H
; Fisher, J
LU
; Lilja, G
LU
; Sjövall, F
LU
; Jungner, M
LU
; Lengquist, M
LU
; Kander, T
LU
; Samuelsson, L
; Johansson, J
; Palmnäs, E
; Undén, J
LU
; Oras, J
; Cronhjort, M
; Chew, M
LU
; Linder, A
LU
; Lipcsey, M
; Nielsen, N
LU
; Jakobsen, J C
and Bentzer, P
LU
(Less)
- author collaboration
- organization
-
- Clinical Sciences, Helsingborg
- Anesthesiology and Intensive Care
- SWECRIT (research group)
- Center for cardiac arrest (research group)
- Brain Injury After Cardiac Arrest (research group)
- Neurology, Lund
- Fluid resuscitation in critical illness (research group)
- Teachers at the Medical Programme
- Clinical Research in Anaesthesia and Intensive Care Medicine (research group)
- Anaesthesiology 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)
- Infection Medicine (BMC)
- publishing date
- 2024-05-17
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Humans, Male, Shock, Septic/therapy, Female, Feasibility Studies, Middle Aged, Fluid Therapy/methods, Aged, Intensive Care Units/organization & administration, Sweden
- in
- Critical care (London, England)
- volume
- 28
- issue
- 1
- article number
- 166
- publisher
- BioMed Central (BMC)
- external identifiers
-
- scopus:85193527494
- pmid:38760833
- ISSN
- 1364-8535
- DOI
- 10.1186/s13054-024-04952-w
- language
- English
- LU publication?
- yes
- id
- d7689956-34e9-4523-abfb-cd393c5477dd
- date added to LUP
- 2024-05-26 12:55:18
- date last changed
- 2024-06-24 06:52:12
@article{d7689956-34e9-4523-abfb-cd393c5477dd,
abstract = {{<p>BACKGROUND/PURPOSE: Non-resuscitation fluids constitute the majority of fluid administered for septic shock patients in the intensive care unit (ICU). This multicentre, randomized, feasibility trial was conducted to test the hypothesis that a restrictive protocol targeting non-resuscitation fluids reduces the overall volume administered compared with usual care.</p><p>METHODS: Adults with septic shock in six Swedish ICUs were randomized within 12 h of ICU admission to receive either protocolized reduction of non-resuscitation fluids or usual care. The primary outcome was the total volume of fluid administered within three days of inclusion.</p><p>RESULTS: Median (IQR) total volume of fluid in the first three days, was 6008 ml (interquartile range [IQR] 3960-8123) in the restrictive fluid group (n = 44), and 9765 ml (IQR 6804-12,401) in the control group (n = 48); corresponding to a Hodges-Lehmann median difference of 3560 ml [95% confidence interval 1614-5302]; p < 0.001). Outcome data on all-cause mortality, days alive and free of mechanical ventilation and acute kidney injury or ischemic events in the ICU within 90 days of inclusion were recorded in 98/98 (100%), 95/98 (98%) and 95/98 (98%) of participants respectively. Cognition and health-related quality of life at six months were recorded in 39/52 (75%) and 41/52 (79%) of surviving participants, respectively. Ninety out of 134 patients (67%) of eligible patients were randomized, and 15/98 (15%) of the participants experienced at least one protocol violation.</p><p>CONCLUSION: Protocolized reduction of non-resuscitation fluids in patients with septic shock resulted in a large decrease in fluid administration compared with usual care. A trial using this design to test if reducing non-resuscitation fluids improves outcomes is feasible.</p><p>TRIAL REGISTRATION: Clinicaltrials.gov, NCT05249088, 18 February 2022. https://clinicaltrials.gov/ct2/show/NCT05249088.</p>}},
author = {{Lindén, Anja and Spångfors, M and Olsen, M H and Fisher, J and Lilja, G and Sjövall, F and Jungner, M and Lengquist, M and Kander, T and Samuelsson, L and Johansson, J and Palmnäs, E and Undén, J and Oras, J and Cronhjort, M and Chew, M and Linder, A and Lipcsey, M and Nielsen, N and Jakobsen, J C and Bentzer, P}},
issn = {{1364-8535}},
keywords = {{Humans; Male; Shock, Septic/therapy; Female; Feasibility Studies; Middle Aged; Fluid Therapy/methods; Aged; Intensive Care Units/organization & administration; Sweden}},
language = {{eng}},
month = {{05}},
number = {{1}},
publisher = {{BioMed Central (BMC)}},
series = {{Critical care (London, England)}},
title = {{Protocolized reduction of non-resuscitation fluids versus usual care in septic shock patients (REDUSE) : a randomized multicentre feasibility trial}},
url = {{http://dx.doi.org/10.1186/s13054-024-04952-w}},
doi = {{10.1186/s13054-024-04952-w}},
volume = {{28}},
year = {{2024}},
}