Status:
RECRUITING
Ultra-Protective Lung Ventilation With Extracorporeal CO2 Removal for Moderate ARDS
Lead Sponsor:
University of Bologna
Collaborating Sponsors:
Getinge Group
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Acute respiratory distress syndrome (ARDS) accounts for 10% of all ICU admissions and for 23% of patients requiring mechanical ventilation (MV). Its hospital mortality remains high, ranging from 34% i...
Detailed Description
Acute respiratory distress syndrome (ARDS) represents a form of lung injury that occurs in response to various predisposing events, characterized by inflammation, increased pulmonary vascular permeabi...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- On invasive mechanical ventilation for ≤ 96 hours
- Presence of all of the following conditions for ≤ 24 hours: 100 \< PaO2/FiO2 ≤ 200 after 12 hours of "standardized ventilation" with PEEP ≥ 5; compliance of the respiratory system ≤ 0.5 ml/cmH2O per kg PBW; ventilatory ratio (VR) ≥ 1.5; bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules; respiratory failure not fully explained by cardiac failure or fluid overload
Exclusion
- Pregnancy
- ARDS with PaO2/FiO2\<100 or PaO2/FiO2\>200 under standardized ventilation with PEEP ≥ 5 cmH2O
- Expected duration of mechanical ventilation \< 48 hours
- Severe COPD
- Chronic respiratory insufficiency with home ventilation or oxygen therapy
- Currently receiving ECMO therapy
- Acute brain injury
- Severe liver insufficiency (Child-Pugh scores \>7) or fulminant hepatic failure
- Heparin-induced thrombocytopenia
- Contraindication for systemic anticoagulation
- Platelet count \<50,000/mm3
- Prothrombin time-international normalized ratio (INR) \>1.5
- Patient moribund, decision to limit therapeutic interventions
- End-stage disease
- Unable to provide vascular access for ECCO2-R
- Acute coronary syndrome
- Actual body weight exceeding 1 kg per centimeter of height
- Burns \> 40% total body surface
- Bone marrow transplantation within the last 1 year
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04903262
Start Date
December 1 2024
End Date
March 31 2027
Last Update
April 2 2025
Active Locations (1)
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1
IRCCS AOUBO Policlinico di Sant'Orsola
Bologna, Italy