The HOPE Study – Hypothermia to Optimize Perfusion in ECMO
Not Applicable
- Conditions
- ung failure (ARDS)
- Registration Number
- DRKS00033506
- Lead Sponsor
- Charité - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Adults of any gender
- ARDS according to the Berlin Definition (of any origin)
- Intensive care therapy with invasive mechanical ventilation
- VV-ECMO with blood flow >4.5 lpm
- Deep analgosedation (RASS -5)
Exclusion Criteria
- Severe intra-abdominal, thoracic, gastrointestinal, and/or intracerebral
- Bleedings
- Severe thrombocytopenia (<20)
- Coagulation failure (Prothrombin time <30, Fibrinogen <1)
- Acute liver failure (Bilirubin > 8)
- Uncontrolled shock of any origin (Norepinephrine > 0.4 µg/kg/min)
- Bradycardia <55 bpm
- Pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood flow within the intervention period
- Secondary Outcome Measures
Name Time Method ECMO blood flow after rewarming, time on ECMO, revolutions per minute of the ECMO, internal pressures of the ECMO, ECMO gas flow, duration of ventilation/ventilation parameters, proportion of primary extubation versus tracheotomy, extrapulmonary organ dysfunction, radiological progression of infiltrates, thrombotic and bleeding-related complications, transfusion requirements, hemostatic support, discharge from the Intensive Care Unit (ICU), mortality (30 days), hemolysis, coagulation profile, inflammatory markers, liver/kidney function, catecholamine requirements.