NCT02345681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
171

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

3.9 years

First QC Date

January 20, 2015

Last Update Submit

August 9, 2021

Conditions

Fluid Balance of ICU PatientsFluid Overload

Keywords

furosemideunder strict conditionsnormalizeICU patientsfluid balance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Test Furosemide

EXPERIMENTAL

We will test our furosemide algorithm in one arm

Drug: Furosemide

Classical Strategy

NO INTERVENTION

It's a classical strategy without diuretics

Interventions

FurosemideDRUG
Test Furosemide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 %)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital François Mitterand

Dijon, France

Location

CHD Vendée

La Roche-sur-Yon, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Related Publications (2)

  • 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.

    PMID: 39878152DERIVED

  • 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.

    PMID: 33691730DERIVED

MeSH Terms

Conditions

Edema

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Karim Asehnoune

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

  • Christine LEBERT

    CHD La Roche sur Yon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 26, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

August 10, 2021

Record last verified: 2021-08

Locations

FR(3)