Effects of Fluid Balance Control in Critically Ill Patients: A Multicenter Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- diuretics
- Conditions
- Fluid Shifts
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 1411
- Locations
- 8
- Primary Endpoint
- All-cause mortality at 60 days after inclusion
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Arms & Interventions
Strategy
Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)
Intervention: diuretics
Strategy
Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)
Intervention: albumin
Strategy
Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)
Intervention: fluid restriction
Strategy
Patients have to be weighed every day. Use of an algorithm based on weight changes from day 2 to day 14 in order to reduce weight gain (fluid overload) using diuretics, fluid restriction,albumin, and ultrafiltration (the latter when ongoing renal replacement)
Intervention: renal replacement
Outcomes
Primary Outcomes
All-cause mortality at 60 days after inclusion
Time Frame: 60 days
Vital status collected 60 days after admission; if the patient was dead at the time of assessment, date of death was collected
Secondary Outcomes
- Fluid balance control at day 7(7 days)
- Fluid balance control at day 14(14 days)
- All-cause mortality at 28-day after inclusion(28 days)
- Survival time period at Day 60(60 days)
- All-cause in-hospital mortality(Up to 24 weeks)
- All-cause mortality at 365 days after inclusion(365 days)
- Survival time period at Day 365(365 days)
- Global end-organ damage assessment(28 days)
- Dependence on vasopressor drugs(28 days)
- Dependence on mechanical ventilation(28 days)
- Dependence on renal replacement therapy(60 days)
- Cumulated number of pre-defined adverse events(14 days)