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

Study 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.

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

Conditions
-----------------
Fluid Balance of ICU Patients, Fluid Overload

Intervention / Treatment
-----------------
* Drug: Furosemide


Participation Criteria
=================
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 %)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Furosemide<br>We will test our furosemide algorithm in one arm | Drug: Furosemide<br> <br> |
| No Intervention: Classical Strategy<br>It's a classical strategy without diuretics | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilatory-free days |  | Day 28 | 
| Number of ICU-free days |  | Day 60 | 
| Period of mechanical Ventilation |  | Day 60 | 
| Extubation Failure |  | Day 60 | 
| ICU Period of stay |  | Day 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
furosemide, under strict conditions, normalize, ICU patients, fluid balance