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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02345681
Acronym
IRIHS-REA
Enrollment
171
Registered
2015-01-26
Start date
2015-05-01
Completion date
2019-04-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Balance of ICU Patients, Fluid Overload

Keywords

furosemide, under strict conditions, normalize, ICU patients, fluid balance

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.

Interventions

DRUGFurosemide

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 %)

Design outcomes

Primary

MeasureTime frameDescription
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 60Definition of fluid balance in our study = Patient's weight at randomisation - Patient's initial weight (Kg) defined as the weight at admission

Secondary

MeasureTime frame
Number of ventilatory-free daysDay 28
Number of ICU-free daysDay 60
Period of mechanical VentilationDay 60
Extubation FailureDay 60
ICU Period of stayDay 60

Countries

France

Contacts

PRINCIPAL_INVESTIGATORKarim Asehnoune

Nantes University Hospital

PRINCIPAL_INVESTIGATORChristine LEBERT

Centre Hospitalier Departemental Vendee

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026