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

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

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.

Study Overview

• Status: Completed
• Conditions: Fluid Overload; Fluid Balance of ICU Patients
• Intervention / Treatment: Drug: Furosemide

• Study Type: Interventional
• Enrollment (Actual): 171
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Dijon, France
    • Hopital Francois Mitterand
  • La Roche sur Yon, France
    • CHD Vendee
  • Nantes, France, 44093
    • CHU de NANTES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 %)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Test Furosemide; We will test our furosemide algorithm in one arm	Drug: Furosemide
NO_INTERVENTION: Classical Strategy; 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	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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Karim Asehnoune, CHU de NANTES; Principal Investigator: Christine LEBERT, CHD La Roche sur Yon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2015
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): April 1, 2019

Study Registration Dates

• First Submitted: January 20, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (ESTIMATE): January 26, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: furosemide; fluid balance; ICU patients; under strict conditions; normalize
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Potassium Chloride Symporter Inhibitors; Furosemide
• Other Study ID Numbers: RC14_0268