Comparing early versus late fluid removal in patients on mechanical ventilation

Effect of a Systematic Preventive Versus Curative Strategy of Fluid Removal on the Weaning of Mechanical Ventilation

This study is testing whether giving diuretics early or later helps critically ill patients on mechanical ventilation breathe easier and recover faster.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 410 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Paris)
• Trial ID: NCT04050007 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the timing of diuretic administration in critically ill patients undergoing mechanical ventilation. It compares two approaches: preventive depletion, where diuretics are given early to manage fluid overload, and curative depletion, where diuretics are administered only after pulmonary edema occurs. The study aims to determine which method is more effective in reducing the duration of mechanical ventilation while minimizing metabolic complications. By evaluating patient outcomes, the trial seeks to provide evidence for best practices in managing fluid balance during weaning from mechanical ventilation.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have been intubated and mechanically ventilated for at least 24 hours with a positive fluid balance.

Not a fit: Patients with conditions such as acute right ventricle failure or those on extracorporeal membrane oxygenation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved weaning outcomes and reduced duration of mechanical ventilation for critically ill patients.

How similar studies have performed: Previous studies have shown promising results with similar fluid management strategies, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. age\>18
2. intubation and mechanical ventilation \>= 24 hours
3. cumulative fluid balance judged positive or increase in body weight since admission
4. 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.

   4.4. temperature \>36,0 ◦C and \< 39◦C
5. consent signed by the patient or next of kin or emergency procedure

Exclusion Criteria:

1. extracorporal membrane oxygenation
2. pregnancy or breastfeeding
3. allergy to furosemide, sulfamides or spironolactone
4. tracheotomy
5. hydrocephaly
6. acute right ventricle failure
7. cardiac arrest with estimated poor prognosis
8. already enrolled in an interventional study on weaning from mechanical ventilation
9. Guillain Barre, myasthenia crisis
10. planned extubation on the day
11. criteria of clinical stability (as described above) present since more than 24 hours
12. natremia \> 150 mEq/L, kaliemia \< 3.5 mEq/L, metabolic alkalosis with pH\>7.5
13. administration of iodinated contrast within the last 6 hours
14. ongoing or planned use of artificial kidney within the next 48 hours
15. no affiliation to the health insurance system
16. patient under curatorship
17. imprisoned patient

Where this trial is running

Paris

• GH Pitié Salpêtrière - Charles Foix — Paris, France (RECRUITING)

Study contacts

• Study coordinator: Martin DRES

Conditions: Respiratory Insufficiency