- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02345681
Impact of Rational Control of Fluid Balance in the Intensive Care Unit (IRIHS-REA)
August 9, 2021 updated by: Nantes University Hospital
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
171
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Dijon, France
- Hopital Francois Mitterand
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La Roche sur Yon, France
- CHD Vendee
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Nantes, France, 44093
- CHU de Nantes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Test Furosemide
We will test our furosemide algorithm in one arm
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NO_INTERVENTION: Classical Strategy
It's a classical strategy without diuretics
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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)
Time Frame: Day 60
|
Definition of fluid balance in our study = Patient's weight at randomisation - Patient's initial weight (Kg) defined as the weight at admission
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Day 60
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of ventilatory-free days
Time Frame: Day 28
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Day 28
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Number of ICU-free days
Time Frame: Day 60
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Day 60
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Period of mechanical Ventilation
Time Frame: Day 60
|
Day 60
|
Extubation Failure
Time Frame: Day 60
|
Day 60
|
ICU Period of stay
Time Frame: Day 60
|
Day 60
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karim Asehnoune, CHU de Nantes
- Principal Investigator: Christine LEBERT, CHD La Roche sur Yon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC14_0268
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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