Fluid Balance of ICU PatientsPhase 3IRIHS-REANCT02345681
Impact of Rational Control of Fluid Balance in the Intensive Care Unit
A Phase 3 study testing Furosemide in people with Fluid Balance of ICU Patients and Fluid Overload, run by Nantes University Hospital at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Balance of ICU Patients, Fluid Overload
- What is being tested?
- Furosemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 3 sitesFrance
- Study dates
- May 2015to Apr 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 %)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital François Mitterand
Dijon
CHD Vendée
La Roche-sur-Yon
CHU de Nantes
Nantes, 44093
About this study
Official title: 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.
- Conditions
- Fluid Balance of ICU Patients, Fluid Overload
- Being tested
- Furosemide
- Keywords
- furosemide, under strict conditions, normalize, ICU patients, fluid balance
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
| Study group | Role | What they receive |
|---|---|---|
| Test Furosemide | Experimental | We will test our furosemide algorithm in one arm Receives: Drug: Furosemide |
| Classical Strategy | No intervention | It's a classical strategy without diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 60
Secondary outcomes (5)
Number of ventilatory-free days
Measured: Day 28
Number of ICU-free days
Measured: Day 60
Period of mechanical Ventilation
Measured: Day 60
Extubation Failure
Measured: Day 60
ICU Period of stay
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startMay 2015
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fluid Balance of ICU PatientsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Asehnoune, Principal investigator, Nantes University HospitalChristine LEBERT, Principal investigator, Centre Hospitalier Departemental Vendee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345681
- Sponsor's protocol ID
- RC14_0268
- Acronym
- IRIHS-REA
- Status last verified
- Aug 2021
- First submitted
- 20 Jan 2015
- Last updated
- 14 Sep 2026
- Results posted
- No
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.
PubMed 33691730Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.
PubMed 39878152
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rational Control of Fluid Balance in the Intensive Care Unit.IRIHS-REA
- ClinicalTrials.gov ID
- NCT02345681
- Acronym / sponsor ID
- IRIHS-REA / RC14_0268
- Conditions
- Fluid Balance of ICU Patients, Fluid Overload
- Keywords
- furosemide, under strict conditions, normalize, ICU patients, fluid balance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Furosemide | Experimental | Drug: FurosemideWe will test our furosemide algorithm in one arm |
| Classical Strategy | No intervention | –It's a classical strategy without diuretics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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 %)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide | Drug | Test Furosemide |
Primary outcome
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
5 secondary outcomes
Number of ventilatory-free days
Time frame: Day 28
Number of ICU-free days
Time frame: Day 60
Period of mechanical Ventilation
Time frame: Day 60
Extubation Failure
Time frame: Day 60
ICU Period of stay
Time frame: Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 33691730Cinotti 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.
- Derived from this study: PubMed 39878152Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Asehnoune principal investigator
Nantes University Hospital
Christine LEBERT principal investigator
Centre Hospitalier Departemental Vendee
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Furosemide in people with Fluid Balance of ICU Patients and Fluid Overload, run by Nantes University Hospital at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02345681, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.