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Randomized Controlled Trial
. 2023 Feb 21;27(1):66.
doi: 10.1186/s13054-023-04357-1.

Fluid balance control in critically ill patients: results from POINCARE-2 stepped wedge cluster-randomized trial

Pierre-Edouard Bollaert  1 , Alexandra Monnier  2 , Francis Schneider  3 , Laurent Argaud  4 , Julio Badie  5 , Claire Charpentier  6 , Ferhat Meziani  2 , Michel Bemer  7 , Jean-Pierre Quenot  8 , Marie Buzzi  9   10 , Hervé Outin  11 , Cédric Bruel  12 , Laurent Ziegler  13 , Sébastien Gibot  1 , Jean-Marc Virion  14 , Camille Alleyrat  14 , Guillaume Louis  15 , Nelly Agrinier  14   16
Affiliations
Randomized Controlled Trial

Fluid balance control in critically ill patients: results from POINCARE-2 stepped wedge cluster-randomized trial

Pierre-Edouard Bollaert et al. Crit Care. .

Abstract

Background: In critically ill patients, positive fluid balance is associated with excessive mortality. The POINCARE-2 trial aimed to assess the effectiveness of a fluid balance control strategy on mortality in critically ill patients.

Methods: POINCARE-2 was a stepped wedge cluster open-label randomized controlled trial. We recruited critically ill patients in twelve volunteering intensive care units from nine French hospitals. Eligible patients were ≥ 18 years old, under mechanical ventilation, admitted to one of the 12 recruiting units for > 48 and ≤ 72 h, and had an expected length of stay after inclusion > 24 h. Recruitment started on May 2016 and ended on May 2019. Of 10,272 patients screened, 1361 met the inclusion criteria and 1353 completed follow-up. The POINCARE-2 strategy consisted of a daily weight-driven restriction of fluid intake, diuretics administration, and ultrafiltration in case of renal replacement therapy between Day 2 and Day 14 after admission. The primary outcome was 60-day all-cause mortality. We considered intention-to-treat analyses in cluster-randomized analyses (CRA) and in randomized before-and-after analyses (RBAA).

Results: A total of 433 (643) patients in the strategy group and 472 (718) in the control group were included in the CRA (RBAA). In the CRA, mean (SD) age was 63.7 (14.1) versus 65.7 (14.3) years, and mean (SD) weight at admission was 78.5 (20.0) versus 79.4 (23.5) kg. A total of 129 (160) patients died in the strategy (control) group. Sixty-day mortality did not differ between groups [30.5%, 95% confidence interval (CI) 26.2-34.8 vs. 33.9%, 95% CI 29.6-38.2, p = 0.26]. Among safety outcomes, only hypernatremia was more frequent in the strategy group (5.3% vs. 2.3%, p = 0.01). The RBAA led to similar results.

Conclusion: The POINCARE-2 conservative strategy did not reduce mortality in critically ill patients. However, due to open-label and stepped wedge design, intention-to-treat analyses might not reflect actual exposure to this strategy, and further analyses might be required before completely discarding it. Trial registration POINCARE-2 trial was registered at ClinicalTrials.gov (NCT02765009). Registered 29 April 2016.

Keywords: Clinical trial; Complex intervention; Critical care; 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
CONSORT diagram of patient recruitment in the POINCARE-2 trial
Fig. 2
Fig. 2
Flowchart of critically ill patients recruited and followed up in the POINCARE-2 trial
Fig. 3
Fig. 3
Evolution of the average weight from Day 0 to Day 14 in patients included in cluster-randomized analyses of the POINCARE-2 trial (with 95% confidence interval of mean and sample size as point label). Using a mixed model entering the ICU and patient as random effects and the time period (defined as ≤ 2 vs. > 2 days) interaction with the linear time as a fixed effect, we found no difference in trend between the 2 groups during the second time period (> 2 days): p = 0.39
See this image and copyright information in PMC

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