Effect of fluid balance control in critically ill patients: Design of the stepped wedge trial POINCARE-2

Abstract

A high number of recent studies have shown that a positive fluid balance is independently associated with impaired prognosis in specific populations of patients hospitalized in intensive care unit (ICU): acute kidney injury, acute respiratory distress syndrome (ARDS), sepsis, high risk surgery. However, to date, there is no evidence that control of fluid overload reduces mortality in critically ill patients.The main objective is to assess the efficacy of a strategy limiting fluid overload on mortality in unselected critically ill patients hospitalized in ICU. We hypothesized that a strategy based on a weight-driven recommendation of restricted fluid intake, diuretics, and ultrafiltration initiated from 48 hours up to 14 days after admission in critically ill patients would reduce all-cause mortality as compared to usual care. We use a stepped wedge cluster randomized controlled trial combined with a quasi-experimental (before-and-after) study. Patients under mechanical ventilation, admitted since > 48h and <72h in ICU, and with no discharge planned for the next 24h are eligible. A total of 1,440 patients are expected to be enrolled in 12 ICUs. Sociodemographic and clinical data are collected at inclusion, and outcomes are collected during the follow-up. Primary outcome is all-cause mortality at 60 days after admission. Secondary outcomes are patients weight differences between admission and day7 (or day 14), 28-day, in-hospital, and 1-year mortality, end-organ damages, and unintended harmful events. Analyses will be held in intention-to-treat. If POINCARE-2 strategy proves effective, then guidelines on fluid balance control might be extended to all critically ill patients.

Restrictive fluid management versus usual care in acute kidney injury (REVERSE-AKI): a pilot randomized controlled feasibility trial

“…A dynamic intervention bundle such as ours may be more suitable for AKI patients who represent a heterogeneous group of patients with some having severely reduced urine output significantly affecting the achievable fluid output while others have a creatinine rise but preserved urine output. A French stepped wedge cluster RCT is assessing another dynamic approach among general ICU patients [ 33 ]. The trial intervention involves fluid restriction and/or enhancement of fluid output to achieve a daily weight loss of 0.5 kg in patients with increasing daily weight [ 33 ].…”

“…A French stepped wedge cluster RCT is assessing another dynamic approach among general ICU patients [ 33 ]. The trial intervention involves fluid restriction and/or enhancement of fluid output to achieve a daily weight loss of 0.5 kg in patients with increasing daily weight [ 33 ]. However, no results are yet available.…”

Acute kidney injury in the critically ill: an updated review on pathophysiology and management

“…Similarly, a strategy of active fluid restriction after initial fluid resuscitation in patients with septic shock was associated with less AKI progression [93] but this finding could not be reproduced in two subsequent trials using a similar approach [94,95]. The results of ongoing RCTs examining the effectiveness and safety of fluid restriction and the role of active de-resuscitation in highrisk patients are awaited [96].…”

Nierenersatztherapie auf der Intensivstation

“…Es ist also möglich, dass wir bald neben der fluid challenge auch eine ultrafiltration challange auf der Intensivstation praktizieren. Eine rezente post-hoc-Analyse der RENAL-Studie legt jedoch die Vermutung nahe, dass der Flüssigkeitsentzug pro Stunde und kg KG nicht ad libidum gesteigert werden sollte [23].…”