Clinical trial NCT02765009: Effects of Fluid Balance Control in Critically Ill Patients
Official title: Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Shifts
Critical Care
Keywords: Fluid overload
Multiple organ failure
Diuretics
Fluid restriction
Body weight
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2016-05-06
Enrollment: 1411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients under mechanical ventilation, admitted for \> 48h and \<72h and no discharge planned for the next 24h

Exclusion Criteria:

* Age \< 18 years
* Failure to weigh the patient
* Multiple trauma
* Transfer from another ICU with a previous stay \> 24h
* High probability of withdrawing treatment for ethical purposes within 7 days
* Pregnancy
* Patient refusal

Primary outcomes:
measure: All-cause mortality at 60 days after inclusion
timeFrame: 60 days
Secondary outcomes:
measure: Fluid balance control at day 7
timeFrame: 7 days
measure: Fluid balance control at day 14
timeFrame: 14 days
measure: All-cause mortality at 28-day after inclusion
timeFrame: 28 days
measure: All-cause in-hospital mortality
timeFrame: Up to 24 weeks
measure: All-cause mortality at 365 days after inclusion
timeFrame: 365 days
measure: Survival time period at Day 60
timeFrame: 60 days
measure: Survival time period at Day 365
timeFrame: 365 days
measure: Global end-organ damage assessment
timeFrame: 28 days
measure: Dependence on vasopressor drugs
timeFrame: 28 days
measure: Dependence on mechanical ventilation
timeFrame: 28 days
measure: Dependence on renal replacement therapy
timeFrame: 60 days
measure: Cumulated number of pre-defined adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hopital Nord Franche-Comté
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
city: Lyon
country: France
facility: Centre Hospitalier Universitaire
city: Metz
country: France
facility: Centre Hospitalier Régional
city: Nancy
country: France
facility: Centre Hospitalier Régional et Universitaire
city: Paris
country: France
facility: Groupe Hospitalier Saint Joseph
city: Poissy
country: France
facility: Centre Hospitalier intercommunal
city: Strasbourg
country: France
facility: Centre Hospitalier Régional et Universitaire
city: Strasbourg
country: France
facility: CentreHospitalier Régional et universitaire
city: Thionville
country: France
facility: Centre Hospitalier Régional
city: Verdun
country: France
facility: Centre Hospitalier
Study officials:
affiliation: Central Hospital, Nancy, France
name: El Mehdi Siaghy
role: STUDY_DIRECTOR
References:
citation: Agrinier N, Monnier A, Argaud L, Bemer M, Virion JM, Alleyrat C, Charpentier C, Ziegler L, Louis G, Bruel C, Jamme M, Quenot JP, Badie J, Schneider F, Bollaert PE. Effect of fluid balance control in critically ill patients: Design of the stepped wedge trial POINCARE-2. Contemp Clin Trials. 2019 Aug;83:109-116. doi: 10.1016/j.cct.2019.06.020. Epub 2019 Jun 29.