Role of Active Deresuscitation After Resuscitation: The RADAR-Canada Pilot Clinical Trial

4588

The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of, compliance with, and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit (ICU).

2024-05-01

2025-03-31

2025-06-30

Not yet recruiting

Early phase I

120

Inclusion Criteria: 1. Age 18 years or older 2. Mechanically ventilated for \> 48 hours 3. Calculated volume accumulation \> 3 liters since ICU admission or pitting edema in at least two sites (arms, legs, or trunk) 4. Admitted to ICU for ≤ five days 5. Informed consent obtained from patient or alternate decision-maker Exclusion Criteria: 1. Lack of consent from patient or substitute decision maker or from responsible physician 2. Active bleeding (defined as \> 2 units transfused RBC in past 24 hours) 3. Hemodynamic instability (defined as use of vasopressors \>0.1 µg/kg/minute norepinephrine or equivalent, or increase in vasopressor dose over past 6 hours) 4. Currently receiving dialysis, or plans to initiate dialysis imminently 5. P/F ratio \< 75 6. Subarachnoid hemorrhage 7. Severe traumatic brain injury with admission GCS \<8 8. Diabetic ketoacidosis or hyperosmolar state 9. Acute cardiac failure or cardiogenic shock 10. Suspected or established diabetes insipidus 11. Allergy to furosemide 12. High probability of death within 24 hours -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'RADAR-Canada is a parallel group CT in which study participants are randomized in a 1:1 ratio to protocolized deresuscitation or usual care', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Masking of the health care team will not be feasible as they must administer the intervention', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-03-22