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NCT Number: NCT02345681

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

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.

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Key information

Conditions

Fluid Balance of ICU Patients Edema Fluid Overload Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital François Mitterand, Dijon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 %)

Treatment and study plan

Furosemide

Drug

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)

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: IRIHS-REA

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2015
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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