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

Critical Care

Research

Jean-Marc Virion¹  Camille Alleyrat¹  Marie Buzzi²  Nelly Agrinier²  Alexandra Monnier³  Ferhat Meziani³  Jean-Pierre Quenot⁴  Francis Schneider⁵  Pierre-Edouard Bollaert⁶  Sébastien Gibot⁶  Laurent Argaud⁷  Julio Badie⁸  Guillaume Louis⁹  Michel Bemer^1,10  Cédric Bruel^1,11  Hervé Outin^1,12  Claire Charpentier^1,13  Laurent Ziegler^1,14 

[1] CIC, Epidémiologie Clinique, CHRU Nancy, INSERM, Université de Lorraine, 54000, Nancy, France;CIC, Epidémiologie Clinique, CHRU Nancy, INSERM, Université de Lorraine, 54000, Nancy, France;Université de Lorraine, Apemac, 54000, Nancy, France;Service de Médecine Intensive-Réanimation Médicale, Nouvel Hôpital Civil, CHU Strasbourg, Université de Strasbourg, 67000, Strasbourg, France;Service de Médecine Intensive-Réanimation, CHU Dijon-Bourgogne, 21000, Dijon, France;Service de Médecine Intensive-Réanimation, Hôpital de Hautepierre, CHU Strasbourg, INSERM U 1121, 67000, Strasbourg, France;Service de Réanimation Médicale, CHRU Nancy, Université de Lorraine, 54000, Nancy, France;Service de Réanimation Médicale, Hospices civils de Lyon, Hôpital Edouard Herriot, 69000, Lyon, France;Service de Réanimation Médicale, Hôpital Nord Franche-Comté, 90015, Belfort, France;Service de Réanimation Polyvalente, CHR Metz-Thionville, 57000, Metz, France;Service de Réanimation Polyvalente, CHR Metz-Thionville, 57000, Thionville, France;Service de Réanimation Polyvalente, Groupe Hospitalier Paris Saint-Joseph, 75000, Paris, France;Service de Réanimation, CHI Poissy Saint-Germain, 78303, Poissy, France;Service d’Anesthésie Réanimation Chirurgicale, CHRU Nancy, Université de Lorraine, 54000, Nancy, France;Service d’anesthésie Réanimation, CH Verdun, 55000, Verdun, France;

关键词: Critical care;    Water-electrolyte balance;    Clinical trial;    Complex intervention;   

DOI  :  10.1186/s13054-023-04357-1

 received in 2022-12-21, accepted in 2023-02-12,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundIn 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.MethodsPOINCARE-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).ResultsA 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.ConclusionThe 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.

【 授权许可】

CC BY   
© The Author(s) 2023

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