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Randomized Controlled Trial
. 2023 Nov 6;27(1):426.
doi: 10.1186/s13054-023-04701-5.

Fluid balance control in critically ill patients: results from as-treated analyses of POINCARE-2 randomized trial

Adil Mansouri  1 , Marie Buzzi  2   3 , Sébastien Gibot  4 , Claire Charpentier  5 , Francis Schneider  6 , Guillaume Louis  7 , Hervé Outin  8 , Alexandra Monnier  9 , Jean-Pierre Quenot  10 , Julio Badie  11 , Laurent Argaud  12 , Cédric Bruel  13 , Marc Soudant  1 , Nelly Agrinier  1   14 ; the POINCARE-2 group
Collaborators, Affiliations
Randomized Controlled Trial

Fluid balance control in critically ill patients: results from as-treated analyses of POINCARE-2 randomized trial

Adil Mansouri et al. Crit Care. .

Abstract

Background: Intention-to-treat analyses of POINCARE-2 trial led to inconclusive results regarding the effect of a conservative fluid balance strategy on mortality in critically ill patients. The present as-treated analysis aimed to assess the effectiveness of actual exposure to POINCARE-2 strategy on 60-day mortality in critically ill patients.

Methods: POINCARE‑2 was a stepped wedge randomized controlled trial. Eligible patients were ≥ 18 years old, under mechanical ventilation and had an expected length of stay in ICU > 24 h. POINCARE-2 strategy consisted of daily weighing over 14 days, and subsequent restriction of fluid intake, administration of diuretics, and/or ultrafiltration. We computed a score of exposure to the strategy based on deviations from the strategy algorithm. We considered patients with a score ≥ 75 as exposed to the strategy. We used logistic regression adjusted for confounders (ALR) or for an instrumental variable (IVLR). We handled missing data using multiple imputations.

Results: A total of 1361 patients were included. Overall, 24.8% of patients in the control group and 69.4% of patients in the strategy group had a score of exposure ≥ 75. Exposure to the POINCARE-2 strategy was not associated with 60-day all-cause mortality (ALR: OR 1.2, 95% CI 0.85-1.55; IVLR: OR 1.0, 95% CI 0.76-1.33).

Conclusion: Actual exposure to POINCARE-2 conservative strategy was not associated with reduced mortality in critically ill patients. Trial registration POINCARE-2 trial is registered at ClinicalTrials.gov (NCT02765009). Registered 29 April 2016.

Keywords: Clinical trial; Complex intervention; Critical care; Instrumental variable; Water–electrolyte balance.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of critically ill patients recruited and followed up in the POINCARE-2 trial
Fig. 2
Fig. 2
Effect of the exposure to the POINCARE-2 strategy on vital status at Day60 according to the main cause of admission
See this image and copyright information in PMC

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