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Trial record 74 of 242 for:    furosemide

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02345681
Recruitment Status : Recruiting
First Posted : January 26, 2015
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Fluid Balance of ICU Patients Fluid Overload Drug: Furosemide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Impact of Rational Control of Fluid Balance in the Intensive Care Unit.IRIHS-REA
Study Start Date : May 2015
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

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

Primary Outcome Measures :
  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) [ 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

Secondary Outcome Measures :
  1. Number of ventilatory-free days [ Time Frame: Day 28 ]
  2. Number of ICU-free days [ Time Frame: Day 60 ]
  3. Period of mechanical Ventilation [ Time Frame: Day 60 ]
  4. Extubation Failure [ Time Frame: Day 60 ]
  5. ICU Period of stay [ Time Frame: Day 60 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 %)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02345681

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Contact: Karim Asehnoune

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Hôpital François Mitterand Not yet recruiting
Dijon, France
Contact: Jean-Pierre QUENOT   
CHD Vendée Recruiting
La Roche sur Yon, France
Contact: Christine LEBERT         
Principal Investigator: Christine LEBERT         
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Karim ASEHNOUNE         
Principal Investigator: Karim ASEHNOUNE         
Sub-Investigator: Christophe GUITTON         
Sub-Investigator: Bertrand ROZEC         
Sub-Investigator: Raphael CINOTTI         
Sub-Investigator: Jean REIGNIER         
Sponsors and Collaborators
Nantes University Hospital
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Principal Investigator: Karim Asehnoune CHU DE NANTES
Principal Investigator: Christine LEBERT CHD La Roche sur Yon

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Responsible Party: Nantes University Hospital Identifier: NCT02345681     History of Changes
Other Study ID Numbers: RC14_0268
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Keywords provided by Nantes University Hospital:
under strict conditions
ICU patients
fluid balance
Additional relevant MeSH terms:
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Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action