Dexamethasone + Hyperbaric Oxygen for Carbon Monoxide Poisoning

(COHOST Trial)

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BZ
Overseen ByBrooklin Zimmerman, MSN
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Nebraska
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding dexamethasone, a steroid medication, to hyperbaric oxygen therapy (breathing pure oxygen in a pressurized room) can enhance recovery after carbon monoxide poisoning. Carbon monoxide poisoning can sometimes cause long-term brain problems, and researchers aim to determine if this combination treatment helps prevent such issues. The trial involves two groups: one receiving the steroid with oxygen therapy and another receiving a placebo (inactive treatment) with oxygen therapy. Individuals who have experienced carbon monoxide poisoning and are being treated at Nebraska Medicine might be suitable candidates. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that combining dexamethasone with hyperbaric oxygen therapy (HBO) might benefit people with carbon monoxide poisoning. Dexamethasone, a steroid, often reduces swelling and aids recovery in various conditions.

One study suggested that this combination could improve brain-related symptoms in those affected by carbon monoxide poisoning. Specifically, the study found that using HBO therapy with dexamethasone might lead to better outcomes for patients with certain complications from poisoning.

HBO therapy alone is a common and generally safe treatment for carbon monoxide poisoning, as it helps reduce symptoms. Early findings indicate that adding dexamethasone is well-tolerated. No major safety issues have been reported so far, but since this study is in its early stages, more research is needed to fully understand any risks.

Overall, dexamethasone is already approved for other uses, indicating it is generally safe when used as directed in medical settings.12345

Why are researchers excited about this study treatment for carbon monoxide poisoning?

Researchers are excited about combining dexamethasone with hyperbaric oxygen therapy for carbon monoxide poisoning because it could enhance recovery by reducing inflammation and brain swelling. Unlike current treatments, which mainly focus on removing carbon monoxide from the blood, this approach adds a steroid, dexamethasone, to specifically target inflammatory responses, potentially improving neurological outcomes. Also, while hyperbaric oxygen therapy is a known treatment, adding dexamethasone could offer a new, synergistic method to address the broader effects of carbon monoxide exposure, offering hope for quicker and more comprehensive recovery.

What evidence suggests that this trial's treatments could be effective for carbon monoxide poisoning?

Research has shown that adding dexamethasone to hyperbaric oxygen therapy might enhance recovery from carbon monoxide poisoning. In this trial, participants will receive either hyperbaric oxygen therapy with dexamethasone or hyperbaric oxygen therapy with a saline placebo. Studies suggest that this combination could improve brain recovery. Dexamethasone, a steroid, can reduce swelling and protect the brain from damage. In other brain-related conditions, steroids like dexamethasone often aid recovery. While hyperbaric oxygen is a common treatment for carbon monoxide poisoning, early evidence suggests that adding dexamethasone could increase its effectiveness.26789

Who Is on the Research Team?

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Jeffrey S Cooper, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Hyperbaric Oxygen Therapy with DexamethasoneExperimental Treatment1 Intervention
Group II: Hyperbaric Oxygen Therapy with Placebo (Saline)Placebo Group1 Intervention

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

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Approved in European Union as Dexamethasone for:
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Approved in United States as Dexamethasone for:
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Approved in Canada as Dexamethasone for:
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Approved in Japan as Dexamethasone for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

Citations

The Efficacy of Dexamethasone in Combination With N- ...The primary outcome is the incidence of DNS within six weeks post-treatment. Objective: To determine whether combining Dexamethasone and N-acetylcysteine ...
Combined application of dexamethasone and hyperbaric ...These results indicate that the combined application of dexamethasone and HBO therapy could yield better efficacy for patients with DEACMP and ...
Management of delayed encephalopathy after CO poisoningThe addition of dexamethasone, N-butylphthalide, or XingZhi-YiNao granules into HBO, or butylphthalide into MSC could achieve better neurological recovery in ...
Dexamethasone + Hyperbaric Oxygen for Carbon ...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 ...
Carbon Monoxide Hyperbaric Oxygen With Steroid TherapyThis study looking to see if neurologic outcomes are improved with the addition of dexamethasone. CO poisoning can initiate a free radical ...
Carbon Monoxide Hyperbaric Oxygen With Steroid TherapyThis study looking to see if neurologic outcomes are improved with the addition of dexamethasone. CO poisoning can initiate a free radical mediated process that ...
Real-world effectiveness of hyperbaric oxygen therapy for ...Early HBOT in patients who developed DNS after CO poisoning significantly improved their DNS symptoms, with treatment effects sustained for 1 year after DNS ...
Experience of carbon monoxide poisoning treated with ...Elevated MBP levels in the cerebrospinal fluid (CSF) have been associated with DNS, and steroid therapy has been shown to reduce MBP levels and ...
Hyperbaric oxygen therapy attenuates carbon monoxide ...This study aimed to elucidate how mitochondrial dynamics and Pink1/Parkin-mediated mitophagy contribute to CO-induced lung injury and to evaluate the ...
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