Safety Study of Inhaled Carbon Monoxide to Treat Acute Respiratory Distress Syndrome (ARDS)

Completed · Phase 1 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome (ARDS)

In brief

The purpose of this study is to assess the safety of inhaled carbon monoxide (iCO) in intubated patients with sepsis-induced ARDS.

Key facts

Study ID

NCT02425579

Run by

Brigham and Women's Hospital

People needed

12

Starts

2015-04-01

Expected to finish

2019-08-01

Last updated by the study team

2019-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with sepsis are defined as those with suspected or documented infection:
• Suspected or proven infection: Sites of infection include thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system
• All eligible patients meet the new definition of sepsis (suspected or proven infection and a SOFA ≥ 2) as PaO2/FiO2 ratio < 300 = 2 SOFA points.
• 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 infiltrates consistent with pulmonary edema on frontal chest radiograph
• A need for positive pressure ventilation by an endotracheal or tracheal tube
• No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
• ARDS onset is defined as the time the last of criteria 1-4 are met. ARDS must persist through the enrollment time window of 120 hours.
• Infiltrates considered "consistent with pulmonary edema" include any infiltrates not fully explained by mass, atelectasis, or effusion or opacities known to be chronic (greater than 1 week). Vascular redistribution, indistinct vessels, and indistinct heart borders alone are not considered "consistent with pulmonary edema" and thus would not count as qualifying opacities for this study.

You may not qualify if…

• Age less than 18 years
• Greater than 120 hours since ARDS onset
• Pregnant or breast-feeding
• 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
• Physician refusal to allow enrollment in the trial
• Moribund patient not expected to survive 24 hours
• No arterial line/no intent to place an arterial line
• No intent/unwillingness to follow lung protective ventilation strategy
• Severe hypoxemia defined as oxygenation saturation (SpO2) <95 or PaO2 <80 on FiO2 ≥0.8
• Hemoglobin < 7.5 g/dl or hemoglobin < 8 g/dl and actively bleeding
• 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 New York Heart Association (NYHA) class IV
• Stroke (ischemic or hemorrhagic) within the prior 3 months
• Diffuse alveolar hemorrhage from vasculitis
• Use of high frequency ventilation
• Participation in other interventional studies involving investigational agents
• Burns > 40% total body surface area
• Use of inhaled pulmonary vasodilator therapy (eg. NO or prostaglandins)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Weill Cornell Medical College/NewYork-Presbyterian — New York, New York, United States
• Duke Univesity Hospital — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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