Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Massachusetts General Hospital
Weill Medical College of Cornell University
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will be a multi-center, prospective, randomized, partially double-blind, placebo-controlled Phase II clinical trial of inhaled CO (iCO) for the treatment of ARDS. The trial will be conducte...
Detailed Description
Acute respiratory distress syndrome (ARDS) is a devastating disease affecting military, veteran, and civilian populations. ARDS is a syndrome of severe acute lung inflammation and hypoxemic respirator...
Eligibility Criteria
Inclusion
- All intubated patients ≥ 18 years old with ARDS
- ARDS is defined when all four of the following criteria are met:
- A PaO2/FiO2 ratio ≤ 300 with at least 5 cm H2O positive end-expiratory airway pressure (PEEP)
- Bilateral opacities on frontal chest radiograph (not fully explained by effusions, lobar/lung collapse, or nodules) within 1 week of a known clinical insult or new or worsening respiratory symptoms
- A need for positive pressure ventilation by an endotracheal or tracheal tube
- Respiratory failure not fully explained by cardiac failure or fluid overload; need objective assessment (e.g., echocardiography) to exclude hydrostatic edema if no risk factor present.
- ARDS onset is defined as the time the last of criteria 1-4 are met. ARDS must persist through the enrollment time window of 168 hours.
Exclusion
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Age less than 18 years
- Greater than 168 hours since ARDS onset
- Pregnant or breastfeeding
- Prisoner
- Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- No consent/inability to obtain consent or appropriate legal representative not available
- Physician refusal to allow enrollment in the trial
- Moribund patient not expected to survive 24 hours
- No arterial or central line/no intent to place an arterial or central line
- No intent/unwillingness to follow lung protective ventilation strategy
- Severe hypoxemia defined as SpO2 \< 95 or PaO2 \< 90 on FiO2 ≥ 0.9
- Hemoglobin \< 7.0 g/dL
- Subjects who are Jehovah's Witnesses or are otherwise unable or unwilling to receive blood transfusions during hospitalization
- Acute myocardial infarction (MI) or acute coronary syndrome (ACS) within the last 90 days
- Coronary artery bypass graft (CABG) surgery within 30 days
- Angina pectoris or use of nitrates with activities of daily living
- Cardiopulmonary disease classified as NYHA class IV
- Stroke (ischemic or hemorrhagic) within the prior 1 month, cardiac arrest requiring CPR within the prior 72 hours, or inability to assess mental status following cardiac arrest
- Burns \> 40% total body surface area (TBSA)
- Severe airway inhalational injury
- Use of high frequency oscillatory ventilation
- Use of extracorporeal membrane oxygenation (ECMO)
- Concomitant use of inhaled pulmonary vasodilator therapy (eg. nitric oxide \[NO\] or prostaglandins)
- Diffuse alveolar hemorrhage from vasculitis
- Concurrent participation in other investigational drug study
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03799874
Start Date
July 1 2019
End Date
January 1 2026
Last Update
August 24 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Washington University
St Louis, Missouri, United States, 63130
4
New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215