Status:
RECRUITING
Preventive Versus Curative Treatment of Fluid Overload
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fluid overload is associated with a poor prognosis in critically ill patients, especially during weaning from mechanical ventilation as it may promote weaning induced pulmonary edema. Previous data su...
Detailed Description
Mechanical ventilation is a cornerstone treatment for critically ill patients that is however associated with complications that may alter the prognosis. A major objective is therefore to separate pat...
Eligibility Criteria
Inclusion
- age\>18
- intubation and mechanical ventilation \>= 24 hours
- cumulative fluid balance judged positive or increase in body weight since admission
- clinical stability as defined by: 4.1. stable oxygenation (SpO2 ≥ 90 % with FiO2 ≤ 50 % and positive end-expiratory pressure (PEEP) ≤ 8 cm H2O) 4.2. stable hemodynamics (no pressors, no fluid expansion within the last 12 hours) 4.3. stopped or decreased sedation within the last 48 hours and stable neurologic state.
- 4. temperature \>36,0 ◦C and \< 39◦C
- consent signed by the patient or next of kin or emergency procedure
Exclusion
- extracorporal membrane oxygenation
- pregnancy or breastfeeding
- allergy to furosemide, sulfamides or spironolactone
- tracheotomy
- hydrocephaly
- acute right ventricle failure
- cardiac arrest with estimated poor prognosis
- already enrolled in an interventional study on weaning from mechanical ventilation
- Guillain Barre, myasthenia crisis
- planned extubation on the day
- criteria of clinical stability (as described above) present since more than 24 hours
- natremia \> 150 mEq/L, kaliemia \< 3.5 mEq/L, metabolic alkalosis with pH\>7.5
- administration of iodinated contrast within the last 6 hours
- ongoing or planned use of artificial kidney within the next 48 hours
- no affiliation to the health insurance system
- patient under curatorship
- imprisoned patient
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT04050007
Start Date
February 1 2020
End Date
March 1 2024
Last Update
January 17 2024
Active Locations (1)
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1
GH Pitié Salpêtrière - Charles Foix
Paris, France, 75013