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

Fluid Overload Clinical Trial

— IRIHS-REA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345681
• Other study ID #: RC14_0268
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: April 2019

Study information

• Verified date: August 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 %)

Related Conditions & MeSH terms

• Fluid Balance of ICU Patients
• Fluid Overload

Intervention

Drug:
• Furosemide

Locations

Country	Name	City	State
France	Hôpital François Mitterand	Dijon
France	CHD Vendée	La Roche sur Yon
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Definition of fluid balance in our study = Patient's weight at randomisation - Patient's initial weight (Kg) defined as the weight at admission	Day 60
Secondary	Number of ventilatory-free days		Day 28
Secondary	Number of ICU-free days		Day 60
Secondary	Period of mechanical Ventilation		Day 60
Secondary	Extubation Failure		Day 60
Secondary	ICU Period of stay		Day 60