Impact of Rational Control of Fluid Balance in the Intensive Care Unit

Phase 3

Completed

• Conditions: Fluid Overload; Fluid Balance of ICU Patients
• Interventions: Drug: Furosemide

• Registration Number: NCT02345681
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-23
• Study First Posted: 2015-01-26
• Study Start: 2015-05
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-09
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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

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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 %)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Furosemide	Furosemide	We will test our furosemide algorithm in one arm

Primary Outcome Measures

Name	Time	Method
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)	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 Outcome Measures

Name	Time	Method
Number of ICU-free days	Day 60
Number of ventilatory-free days	Day 28
Period of mechanical Ventilation	Day 60
Extubation Failure	Day 60
ICU Period of stay	Day 60

Trial Locations

Locations (3)

CHD Vendée; 🇫🇷 La Roche sur Yon, France

Hôpital François Mitterand; 🇫🇷 Dijon, France

CHU de Nantes; 🇫🇷 Nantes, France