Safety Study of Inhaled Carbon Monoxide to Treat Pneumonia and Sepsis-Induced Acute Respiratory Dā¦ (NCT04870125) | Clinical Trial Compass
Active ā Not RecruitingPhase 1
Safety Study of Inhaled Carbon Monoxide to Treat Pneumonia and Sepsis-Induced Acute Respiratory Distress Syndrome (ARDS)
United States5 participantsStarted 2023-12-06
Plain-language summary
This study is a multi-center, randomized, partially double-blind, and placebo-controlled Phase Ib clinical trial of inhaled CO (iCO) for the treatment of sepsis-induced acute respiratory distress syndrome (ARDS). The purpose of this study is to evaluate the safety and accuracy of a Coburn-Forster-Kane (CFK) equation-based personalized iCO dosing algorithm to achieve a target carboxyhemoglobin (COHb) level of 6-8% in patients with sepsis-induced ARDS. We will also examine the biologic readouts of low dose iCO therapy in patients with sepsis-induced ARDS.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Suspected or proven infection: Sites of infection include thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system
ā. Increase in Sequential Organ Failure Assessment (SOFA) Score ā„ 2 over baseline
ā. A PaO2/FiO2 ratio ā¤ 300 with at least 5 cm H2O positive end-expiratory airway pressure (PEEP)
ā. 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
ā. A need for positive pressure ventilation by an endotracheal or tracheal tube
ā. 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 is present
Exclusion criteria
ā. Age less than 18 years
ā. Greater than 168 hours since ARDS onset
What they're measuring
1
Primary Safety Outcome: Number of pre-specified administration-related adverse events (AEs).
Timeframe: 7 days
2
Accuracy of the Coburn-Forster-Kane (CFK) equation-based personalized iCO dosing algorithm to achieve a COHb level of 6-8%
ā. 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)
ā. No consent/inability to obtain consent or appropriate legal representative not available
ā. Physician refusal to allow enrollment in the trial
ā. Moribund patient not expected to survive 24 hours