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Clinical Trials/NCT02345681
NCT02345681
Completed
Phase 3

Impact of Rational Control of Fluid Balance in the Intensive Care Unit.IRIHS-REA

Nantes University Hospital3 sites in 1 country171 target enrollmentMay 2015

Overview

Phase
Phase 3
Intervention
Furosemide
Conditions
Fluid Balance of ICU Patients
Sponsor
Nantes University Hospital
Enrollment
171
Locations
3
Primary Endpoint
Evolution of fluid balance between randomisation and extubation (fluid balance in our study = Patient's weight at randomisation - Patient's initial weight (Kg) defined as the weight at admission)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Patients admitted in the Intensive Care Unit (ICU) frequently display and excessive fluid balance over a very short period of time. This positive fluid balance is the consequence of different organ failures (pulmonary, cardio-vascular, kidney...) or aggressive fluid resuscitation, which is mandatory in the early phase of ICU course. However recent data strongly suggest that an excessive fluid balance could be detrimental per se (increase of ICU morbidity or even mortality). There are controversies regarding the potential benefit of controlling this fluid balance with diuretics which are commonly used worldwide in various indications (acute and chronic heart failure, chronic kidney failure). In the ICU literature data are lacking, regarding the possible advantages and drawbacks of diuretics in this indication. The aim of our study is to test an algorithm with furosemide to reduce fluid overload in severe ICU-patients.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
April 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age of 18 or more
  • Patients receiving endo-tracheal intubation and mechanical ventilation during their stay in the ICU
  • Weight increase of at least 3 % during the stay. Baseline weight is regarded as the weight at the 24th hour after ICU admission
  • FiO2 \< 60 %, PEEP \< 10cmH20
  • No administration of catecholamines other than dobutamine at a dose of 10 microg.Kg-1.min-1

Exclusion Criteria

  • Pregnancy
  • Patient with a moribund state at ICU arrival
  • Acute brain injury (traumatic brain injury, subarachnoid hemorrhage, intra-cerebral bleeding, stroke, meningo-encephalitis, coma from medication origin)
  • Chronic kidney disease defined as creatinin clearance \< 30mL.min-1 and/or with chronic dialysis
  • Mandatory administration of diuretics (cardiogenic pulmonary oedema, LVEF \< 30 %)

Arms & Interventions

Test Furosemide

We will test our furosemide algorithm in one arm

Intervention: Furosemide

Outcomes

Primary Outcomes

Evolution of fluid balance between randomisation and extubation (fluid balance in our study = Patient's weight at randomisation - Patient's initial weight (Kg) defined as the weight at admission)

Time Frame: Day 60

Definition of fluid balance in our study = Patient's weight at randomisation - Patient's initial weight (Kg) defined as the weight at admission

Secondary Outcomes

  • Extubation Failure(Day 60)
  • Number of ICU-free days(Day 60)
  • Number of ventilatory-free days(Day 28)
  • Period of mechanical Ventilation(Day 60)
  • ICU Period of stay(Day 60)

Study Sites (3)

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