Trial reportCritical care (London, England)2023
Fluid balance control in critically ill patients: results from POINCARE-2 stepped wedge cluster-randomized trial.
Trial report in Critical care (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02765009 (Effects of Fluid Balance Control in Critically Ill Patients), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Role of recruitment bias in stepped-wedge cluster randomised controlled trials: a systematic review.BMJ open · 2025Pooled it
- Impact on fluid balance of an optimized restrictive strategy targeting non-resuscitative fluids in intensive care patients with septic shock: a single-blind, multicenter, randomized, controlled, pilot study.Critical care (London, England) · 2024Trial
- Fluid balance neutralization secured by hemodynamic monitoring versus protocolized standard of care in patients with acute circulatory failure requiring continuous renal replacement therapy: results of the GO NEUTRAL randomized controlled trial.Intensive care medicine · 2024Trial
- Implementation of a fluid balance control strategy in critically ill patients: POINCARE-2 trial process evaluation.BMC medical research methodology · 2024Trial
- Fluid balance control in critically ill patients: results from as-treated analyses of POINCARE-2 randomized trial.Critical care (London, England) · 2023Trial
- The fluid paradox: dissociation between clinical and ultrasound parameters of fluid overload - results of the INCIVEX exploratory study.Anaesthesiology intensive therapy · 2026Observational
- Association of fluid balance with 3-month outcomes in severe acute ischaemic stroke.Stroke and vascular neurology · 2026Article
- Association of active fluid de-escalation timing with clinical outcomes in patients with septic shock: a multicenter cohort study.BMC infectious diseases · 2026Article
- Association of fluid balance trajectories and cumulative fluid balance with in-hospital mortality in patients with acute pancreatitis.Frontiers in medicine · 2026Article
- Article
- Ten tips on how to reduce iatrogenic acute kidney injury.Clinical kidney journal · 2025Review
- Exploring Aquaporins in Human Studies: Mechanisms and Therapeutic Potential in Critical Illness.Life (Basel, Switzerland) · 2024Review
- [The ROSE concept: modern fluid management in intensive care medicine].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2024Article
- The times are changing: A primer on novel clinical trial designs and endpoints in critical care research.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2024Article
- Fluid accumulation syndrome in sepsis and septic shock: pathophysiology, relevance and treatment-a comprehensive review.Annals of intensive care · 2024Review
- Development of early prediction model of in-hospital cardiac arrest based on laboratory parameters.Biomedical engineering online · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
Abstract
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.