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Gasotransmitter

Inhaled Carbon Monoxide for ARDS

Phase 1

Waitlist Available

Led By Laura E Fredenburgh, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with sepsis defined as those with life-threatening organ dysfunction caused by a dysregulated host response to infection with suspected or proven infection at various sites

ARDS defined by specific criteria including PaO2/FiO2 ratio ≤ 300, bilateral opacities on frontal chest radiograph, need for positive pressure ventilation, and respiratory failure not fully explained by cardiac failure or fluid overload

Must not have

Various medical conditions including recent acute myocardial infarction, coronary artery bypass graft surgery, severe cardiopulmonary disease, stroke, burns, airway inhalational injury, use of specific ventilation or oxygenation therapies, diffuse alveolar hemorrhage, and concurrent participation in other investigational drug study

Age less than 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months

Summary

This trial is testing a potential new treatment for sepsis-induced acute respiratory distress syndrome (ARDS) which could help improve safety and accuracy when compared to current methods.

Who is the study for?

Adults with sepsis-induced ARDS, meeting specific criteria including a PaO2/FiO2 ratio ≤ 300 and requiring positive pressure ventilation. Excluded are those under 18, pregnant or breastfeeding women, patients without arterial/central lines, those not expected to survive 24 hours, and others with certain medical conditions.

What is being tested?

The trial tests personalized doses of inhaled Carbon Monoxide (200-500 ppm) to achieve COHb levels of 6-8% against inhaled medical air for safety and effectiveness in treating sepsis-induced ARDS. It's randomized and partially double-blind.

What are the potential side effects?

Potential side effects may include symptoms related to carbon monoxide exposure such as headache, dizziness, weakness, nausea or vomiting; however the study aims at controlled low-dose exposure to minimize risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have sepsis with organ dysfunction due to an infection.

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I have severe lung condition not caused by heart failure, needing a ventilator.

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I am 18 or older and have been diagnosed with sepsis and ARDS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe heart, lung conditions, recent major surgeries, or participated in another drug study recently.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Accuracy of the Coburn-Forster-Kane (CFK) equation-based personalized iCO dosing algorithm to achieve a COHb level of 6-8%

Primary Safety Outcome: Number of pre-specified administration-related adverse events (AEs).

Secondary study objectives

Dead Space Fraction (Vd/Vt) on days 1-3 and day 7

Hayling Sentence Completion Test

Hospital mortality to day 28 and 60

+8 more

Other study objectives

Change in biomarkers of inflammasome activation

Change in biomarkers of mitochondrial dysfunction

Change in biomarkers of necroptosis

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Inhaled Carbon MonoxideExperimental Treatment1 Intervention

Inhaled Carbon Monoxide at CFK equation-determined personalized dose (200-500 ppm to achieve a COHb level of 6-8%) for up to 90 minutes daily for 3 days.

Group II: Medical airPlacebo Group1 Intervention

Inhaled Medical Air for up to 90 minutes daily for 3 days.

0 / 5Eligibility criteria met