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Clinical Trials/NCT02765009
NCT02765009
Completed
Not Applicable

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

Central Hospital, Nancy, France8 sites in 1 country1,411 target enrollmentJune 1, 2016

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
May 25, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

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)

Study Sites (8)

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