← Back to Search

Gasotransmitter

Inhaled Carbon Monoxide for ARDS

Phase 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have sepsis with organ dysfunction due to an infection.

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER

1,937 Previous Clinical Trials

2,299,720 Total Patients Enrolled

9 Trials studying Sepsis

21,480 Patients Enrolled for Sepsis

Brigham and Women's HospitalLead Sponsor

1,615 Previous Clinical Trials

11,470,794 Total Patients Enrolled

5 Trials studying Sepsis

26,773 Patients Enrolled for Sepsis

Duke UniversityOTHER

2,363 Previous Clinical Trials

3,420,450 Total Patients Enrolled

14 Trials studying Sepsis

53,671 Patients Enrolled for Sepsis

Media Library

Inhaled Carbon Monoxide (Gasotransmitter) Clinical Trial Eligibility Overview. Trial Name: NCT04870125 — Phase 1

Sepsis Research Study Groups: Medical air, Inhaled Carbon Monoxide

Sepsis Clinical Trial 2023: Inhaled Carbon Monoxide Highlights & Side Effects. Trial Name: NCT04870125 — Phase 1

Inhaled Carbon Monoxide (Gasotransmitter) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04870125 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants in this trial?

"At present, this clinical trial is not enrolling patients. It was first posted on the 1st of September 2022 and last edited on 4th June 2022. If you are seeking alternative studies consider that there currently 1685 trials recruiting pyemia participants, as well 2 for Inhaled Carbon Monoxide with CFK equation-determined personalized dose (200-500 ppm to achieve a COHb level of 6-8%)."

Answered by AI

What is the potential hazard of Inhaled Carbon Monoxide at a personalized dose (200-500 ppm to achieve a COHb level of 6-8%)?

"The safety rating for Inhaled Carbon Monoxide at CFK equation-determined personalized dose (200-500 ppm to achieve a COHb level of 6-8%) is 1 due to its Phase 1 status, which indicates that data supporting both efficacy and safety are sparse."

Answered by AI

Are there other research endeavors that have sought to utilize the CFK equation in order to ascertain an ideal Carbon Monoxide inhalation dosage (200-500 ppm for a COHb level of 6-8%)?

"Currently, two clinical trials are underway to evaluate the potential benefits of Inhaled Carbon Monoxide administered according to a CFK-derived personalized dosage (200-500 ppm for targeted carboxyhemoglobin levels of 6-8%). No research has yet reached Phase 3. Though many of these studies originate in New york City, they span 12 distinct sites worldwide."

Answered by AI

Is enrollment for this clinical trial open to the public at present?

"Currently, no recruitment is taking place for this medical research. Initially posted on September 1st 2022 and last updated 4th June of the same year, there are however 1687 other clinical trials searching for participants at present."

Answered by AI

What is the breadth of this trial's implementation?

"At present, 4 medical centres are running this trial. Durham, Boston and Saint Louis are only a few of the locations being used for recruitment. To reduce strain on participants, it is advisable to select the closest clinic possible."

Answered by AI

What primary goals have been identified in this experiment?

"The main focus of this trial, which will be monitored over a one-week period, is to accurately ascertain the efficacy of the Coburn-Forster-Kane (CFK) equation-based personalized iCO dosing algorithm in achieving a COHb level between 6 and 8%. Amongst other secondary objectives, there are assessments that involve administering The Hayling Sentence Completion Test via telephone interviews at three month intervals. This neuropsychological test consists of two parts; time taken to complete sentences as well as their quality being measured for both. Additionally, PaO2/FiO2 ratios must be calculated on days 1"

Answered by AI

Recent research and studies

American Journal of Physiology-Lung Cellular and Molecular PhysiologyJournal

Effects of Inhaled CO Administration on Acute Lung Injury in Baboons with Pneumococcal Pneumonia

Fredenburgh, Laura E., Bryan D. Kraft, Dean R. Hess, R. Scott Harris, Monroe A. Wolf, Hagir B. Suliman, Victor L. Roggli, et al.. 2015. “Effects of Inhaled CO Administration on Acute Lung Injury in Baboons with Pneumococcal Pneumonia”. American Journal of Physiology-lung Cellular and Molecular Physiology. American Physiological Society. doi:10.1152/ajplung.00240.2015.

ChestJournal

A Phase II Clinical Trial of Low-dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis

Rosas, Ivan O., Hilary J. Goldberg, Harold R. Collard, Souheil El-Chemaly, Kevin Flaherty, Gary M. Hunninghake, Joseph A. Lasky, et al.. 2018. “A Phase II Clinical Trial of Low-dose Inhaled Carbon Monoxide in Idiopathic Pulmonary Fibrosis”. Chest. Elsevier BV. doi:10.1016/j.chest.2017.09.052.

Journal of Applied PhysiologyJournal

Predicting the Carboxyhemoglobin Levels Resulting from Carbon Monoxide Exposures

Peterson, J. E., and R. D. Stewart. 1975. “Predicting the Carboxyhemoglobin Levels Resulting from Carbon Monoxide Exposures”. Journal of Applied Physiology. American Physiological Society. doi:10.1152/jappl.1975.39.4.633.

Journal of Applied PhysiologyJournal