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Randomized Controlled Trial
. 2024 May 17;28(1):166.
doi: 10.1186/s13054-024-04952-w.

Protocolized reduction of non-resuscitation fluids versus usual care in septic shock patients (REDUSE): a randomized multicentre feasibility trial

Anja Lindén  1   2 , M Spångfors  3   4 , M H Olsen  5   6 , J Fisher  3 , G Lilja  7   8 , F Sjövall  3   9 , M Jungner  3   9 , M Lengquist  3   10 , T Kander  3   10 , L Samuelsson  11 , J Johansson  11 , E Palmnäs  12 , J Undén  3   12 , J Oras  13 , M Cronhjort  14 , M Chew  15 , A Linder  16 , M Lipcsey  17   18 , N Nielsen  3   19 , J C Jakobsen  4   20 , P Bentzer  3   19 ; REDUSE Trial Group
Collaborators, Affiliations
Randomized Controlled Trial

Protocolized reduction of non-resuscitation fluids versus usual care in septic shock patients (REDUSE): a randomized multicentre feasibility trial

Anja Lindén et al. Crit Care. .

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 (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.

Keywords: Feasibility; Fluid therapy; Non-resuscitation fluids; Randomized controlled trial; Septic shock.

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Conflict of interest statement

The authors declare no competing interests.

The authors have no competing interests to declare.

Figures

Fig. 1
Fig. 1
CONSORT flowchart. *Includes eight patients that were not eligible. Patients are labelled “lost to follow-up” if all outcome data were missing. If some of the outcome data were missing, the patient is labelled as “missing data”. VP: vasopressor
Fig. 2
Fig. 2
A: Total volume of fluids administered during the first three days (D0-3) in the ICU. B: Total daily fluid volume the first five days in the ICU. n indicates number of patients
See this image and copyright information in PMC

Comment in

  • Trials and the importance of usual care.
    White KC, Laupland KB, Bellomo R; Queensland Critical Care Research Network (QCCRN). White KC, et al. Crit Care. 2024 Jul 8;28(1):223. doi: 10.1186/s13054-024-04977-1. Crit Care. 2024. PMID: 38978092 Free PMC article. No abstract available.

References

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