CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,411 enrolled
Drug / intervention
diuretics +3 moredrug
Likely dose
Not stated in record
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Search/NCT02765009
NCT02765009N/ACompleted

Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study

Central Hospital, Nancy, France·interventional·Posted May 6, 2016·Updated Sep 22, 2020

In Brief

A clinical study evaluating diuretics, albumin, and 2 other interventions for Fluid Shifts and Critical Care. Completed, enrolled 1,411 participants across 11 sites.

Detailed Summary

Most ICU patients develop a positive fluid balance, mainly during the two first weeks of their stay. The causes are multifactorial: a reduced urine output subsequent to shock state, positive pressure mechanical ventilation, acute renal failure, post-operative period of major surgical procedures, and simultaneous fluid loading to maintain volemia and acceptable arterial pressure. Additionally, the efficacy of fluid loading is frequently suboptimal, in relation to severe hypoalbuminemia and inflammatory capillary leakage. This results usually in a cumulated positive fluid balance of more than 10 litres at the end of the first week of stay. A high number of studies have showed that such a positive fluid balance was an independent factor of worse prognosis in selected populations of ICU patients: acute renal failure, acute respiratory distress syndrome (ARDS), sepsis, post-operative of high risk surgery. However, little is known about the putative causal role of positive fluid balance by itself on outcome. However, in two randomized controlled studies in patients with ARDS, a strategy of fluid balance control has been demonstrated to reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. Although avoiding fluid overload is now recommended in ARDS management, there is no evidence that this approach would be beneficial in a more general population of ICU patients (i.e. with sepsis, acute renal failure, mechanical ventilation). In addition, fluid restriction -mainly if applied early could be deleterious in reducing both tissue oxygen delivery and perfusion pressure. There is a place for a prospective study comparing a "conventional" attitude based on liberal fluid management throughout the ICU stay with a restrictive approach aiming at controlling fluid balance, at least as soon as the patient circulatory status is stabilized. The latter approach would use a simple algorithm using fluid restriction and diuretics based on daily weighing, a common procedure in the ICU, probably more reliable than cumulative measurement of fluid movements in patients whose limits have been underlined.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 6, 2016
Enrollment StartJun 1, 2016
Primary CompletionJul 31, 2019
Study CompletionMay 25, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.2 years ago

Interventions

diureticsdrug

Used to reduce fluid overload as evidenced by weight gain

albumindrug

Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients

fluid restrictionother

Used to reduce fluid overload

renal replacementdevice

Used to reduce fluid overload in patients with renal replacement