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

NCT ID: NCT02345681

Last Updated: 2021-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2019-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fluid Balance of ICU Patients Fluid Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Test Furosemide

We will test our furosemide algorithm in one arm

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Classical Strategy

It's a classical strategy without diuretics

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Furosemide

Intervention Type DRUG

Eligibility Criteria

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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 %)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karim Asehnoune

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Christine LEBERT

Role: PRINCIPAL_INVESTIGATOR

CHD La Roche sur Yon

Locations

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Hôpital François Mitterand

Dijon, , France

Site Status

CHD Vendée

La Roche-sur-Yon, , France

Site Status

CHU de Nantes

Nantes, , France

Site Status

Countries

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France

References

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Hashimoto 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.

Reference Type DERIVED
PMID: 39878152 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33691730 (View on PubMed)

Other Identifiers

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RC14_0268

Identifier Type: -

Identifier Source: org_study_id

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