Clinical trial NCT02345681: Impact of Rational Control of Fluid Balance in the Intensive Care Unit
Official title: Impact of Rational Control of Fluid Balance in the Intensive Care Unit.IRIHS-REA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fluid Balance of ICU Patients
Fluid Overload
Keywords: furosemide
under strict conditions
normalize
ICU patients
fluid balance
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 %)

Primary outcomes:
measure: 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)
timeFrame: Day 60
Secondary outcomes:
measure: Number of ventilatory-free days
timeFrame: Day 28
measure: Number of ICU-free days
timeFrame: Day 60
measure: Period of mechanical Ventilation
timeFrame: Day 60
measure: Extubation Failure
timeFrame: Day 60
measure: ICU Period of stay
timeFrame: Day 60
Other outcomes:
Locations:
city: Dijon
country: France
facility: Hôpital François Mitterand
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Nantes
country: France
facility: CHU de Nantes
Study officials:
affiliation: Nantes University Hospital
name: Karim Asehnoune
role: PRINCIPAL_INVESTIGATOR
affiliation: CHD La Roche sur Yon
name: Christine LEBERT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cinotti R, Lascarrou JB, Azais MA, Colin G, Quenot JP, Mahe PJ, Roquilly A, Gaultier A, Asehnoune K, Reignier J. Diuretics decrease fluid balance in patients on invasive mechanical ventilation: the randomized-controlled single blind, IRIHS study. Crit Care. 2021 Mar 10;25(1):98. doi: 10.1186/s13054-021-03509-5.