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

Nantes University Hospital (NUH)

Status and phase: Completed; Phase 3

Conditions: Fluid Balance of ICU Patients; Fluid Overload

Treatments: Drug: Furosemide

Study type: Interventional

Funder types: Other

Identifiers

NCT02345681

RC14_0268

Details and patient eligibility

About

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.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 %)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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171 participants in 2 patient groups

Test Furosemide

Experimental group

Description:

We will test our furosemide algorithm in one arm

Treatment:

Drug: Furosemide

Classical Strategy

No Intervention group

Description:

It's a classical strategy without diuretics