Dexamethasone + Hyperbaric Oxygen for Carbon Monoxide Poisoning

(COHOST Trial)

Overseen By Brooklin Zimmerman, MSN

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Nebraska

Disqualifiers: Mechanical ventilation, Neurological condition, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 3 days

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Hyperbaric Oxygen Therapy (HBO) is routine treatment of carbon monoxide (CO) poisoning to prevent delayed neurological sequelae. This study looking to see if neurologic outcomes are improved with the addition of dexamethasone. CO poisoning can initiate a free radical mediated process that can instigate a demyelinating process resulting in long term neurological sequelae in some, but not all patients. In other demyelinating disorders, steroids are a part of first line treatment. HBO is already used for acute CO poisoning, so this pilot study will try to ascertain if the addition of steroids in concert with each hyperbaric oxygen session will yield improved outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Dexamethasone for treating carbon monoxide poisoning?

Dexamethasone has been shown to reduce symptoms in conditions like acute mountain sickness, which involves similar issues with oxygen levels in the body. This suggests it might help in carbon monoxide poisoning, which also affects oxygen delivery. ^{1 2 3 4 5}

Is dexamethasone generally safe for humans?

Dexamethasone has been studied for various conditions and is generally considered safe, but it can cause side effects like a decrease in white blood cell count and changes in organ size. It is not likely to cause cancer, but it may affect fetal development in animals. Always consult with a healthcare provider for personalized advice. ^{5 6 7 8 9}

How does the drug Dexamethasone differ from other treatments for carbon monoxide poisoning?

Dexamethasone is unique because it causes less metabolic alkalemia (a condition where the blood becomes too alkaline) compared to other steroids like methylprednisolone or hydrocortisone, which can be important in managing patients in critical care settings. ^{1 2 4 10 11}

Research Team

Jeffrey S Cooper, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for individuals with brain diseases like Parkinson's or those who have suffered from carbon monoxide poisoning. Participants should not have any conditions that exclude them as per the study's criteria, which are not specified here.

Inclusion Criteria

Nebraska Medicine admission

I am over 18 years old.

I am receiving hyperbaric oxygen therapy for carbon monoxide poisoning.

Exclusion Criteria

Allergy to dexamethasone

I am on a mechanical ventilator.

I have not been admitted to the hospital or ICU recently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive hyperbaric oxygen therapy with either dexamethasone or placebo for a minimum of three inpatient sessions

3 days

3 visits (inpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at 2 weeks, 6 weeks, and 12 weeks post-treatment

12 weeks

1 visit (in-person), 2 follow-ups (telephone)

Extension

Continued HBO therapy plus placebo or steroids offered if participants are still dealing with CO poisoning sequelae

Treatment Details

Interventions

• Dexamethasone

Trial Overview The study tests if adding dexamethasone (a steroid) to Hyperbaric Oxygen Therapy improves neurological outcomes in patients with CO poisoning compared to a saline placebo alongside HBO treatment.

Participant Groups

Group I: Hyperbaric Oxygen Therapy with Dexamethasone Experimental Treatment 1 Intervention

Participants will be treated with hyperbaric oxygen (HBO) therapy within three days of acute carbon monoxide poisoning. Treatment is a minimum of three inpatient sessions. Participants will also receive 10 mg dexamethasone per day while receiving HBO therapy (minimum of two doses, maximum of five doses if participants' stay is longer than three days). After three treatment sessions, participants will discharge home, barring no other medical complications requiring further hospitalization. In addition, continued HBO therapy plus steroids will be offered if participants are still dealing with CO poisoning sequelae as determined by study outcome measures.

Group II: Hyperbaric Oxygen Therapy with Placebo (Saline) Placebo Group 1 Intervention

Participants will be treated with hyperbaric oxygen (HBO) therapy within three days of acute carbon monoxide poisoning. Treatment is a minimum of three inpatient sessions. Participants will also a saline placebo instead of dexamethasone while receiving HBO therapy. After three treatment sessions, participants will discharge home, barring no other medical complications requiring further hospitalization. In addition, continued HBO therapy plus steroids will be offered if participants are still dealing with CO poisoning sequelae as determined by study outcome measures.

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

In COVID-19 with hypoxemia, 12 vs. 6 mg/d of dexamethasone did not increase days alive without life support. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Open Investigation Determining Steroid Dose in Severe COVID-19: The ROIDS-Dose Clinical Trial. [2022]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Effect of glucocorticoids on the fractional composition and derivatives of hemoglobin in rats]. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone in the treatment of acute mountain sickness. [2016]

5. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

High-Dose vs. Low-Dose Dexamethasone in Patients With COVID-19: A Cohort Study in Rural Central America. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Preliminary studies of 6 beta-hydroxydexamethasone and its importance in the DST. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Single-dose dexamethasone treatment of hypotension in preterm infants. [2019]

8. Japan pubmed.ncbi.nlm.nih.gov

Dexamethasone (Veterinary medicinal products). [2020]

9. England pubmed.ncbi.nlm.nih.gov

Single dose dexamethasone suppression test in children: dose relationship to body size. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone causes less steroid-induced alkalemia than methylprednisolone or hydrocortisone. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Twenty-four-hour pretreatment with low dose (0.25 mg/kg/dose) versus high dose (0.5 mg/kg/dose) dexamethasone in reducing the risk of postextubation airway obstruction in children: A randomized open-label noninferiority trial. [2021]