Health Condition 1: J80- Acute respiratory distress syndrome
Conditions
Interventions
Intervention1: Aviptadil with Standard of Care: Aviptadil will be administered by infusion pump with 12-hour intervals at ascending doses on 3 successive days. Patients will receive 0.166 mcg/kg/hr of
Sponsors
Zuventus Healthcare Limited
Zuventus Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with >18 years of age. 2. Patients with ARDS, confirmed by the New Global Definition of ARDS, 2024 based on the following diagnostic criteria. 2a). Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS. 2b). Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on High-resolution computed tomography (HRCT). 2c). Patients with respiratory failure not fully explained by cardiac failure or fluid overload; If no risk factor for ARDS is identified, hydrostatic edema must be excluded by objective measures (e.g., echo-cardiography). 2d). Patients with one of the oxygenation criteria: PaO2/FiO2 ratio OR SpO2:FiO2 =30 L/min or NIV/CPAP with PEEP at least 5 cmH2O. 3. Obtained informed consent for participation in the study from the patients or legally acceptable representative
Exclusion criteria
Exclusion criteria: 1. Patients with mechanical ventilation for more than 48 hours prior to ARDS diagnosis. 2. Patients with congestive heart failure. 3. Patients with acute left ventricular failure. 4. Patients with liver failure (Child Pugh grade C). 5. Patients with chronic renal failure requiring renal dialysis therapy. 6. Patients who have burns more than 20% of total body surface area. 7. Patients after resuscitation from cardiac arrest. 8. Patients with a history of hypersensitivity to the anticoagulants. 9. Patients with more than 3 watery stools within 24 hours. 10. Pregnant or lactating women. 11. Decision of the investigator that participation in the study is not in the best interest of the patient or any condition that prevents the safe adherence to the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in PaO2/FiO2 ratio.Timepoint: Baseline and on post-treatment day 1, 2, 3, 4, 5, 6, 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rateTimepoint: Baseline to post-treatment day 7;Oxygenation IndexTimepoint: Baseline, post-treatment day 1, 4 and 7;Change in Sequential Organ Failure Assessment (SOFA) scoreTimepoint: Baseline, post-treatment Day 4 and 7;Duration of stay in hospitalTimepoint: baseline to post-treatment day 7;Incidences of adverse events Timepoint: Baseline to post-treatment day 7 | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Limited
Outcome results
None listed