Dexamethasone + Hyperbaric Oxygen for Carbon Monoxide Poisoning
(COHOST Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive hyperbaric oxygen therapy with either dexamethasone or placebo for a minimum of three inpatient sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment, with evaluations at 2 weeks, 6 weeks, and 12 weeks post-treatment
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?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor
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 ...
3.
journals.lww.com
journals.lww.com/md-journal/fulltext/2019/12060/management_of_delayed_encephalopathy_after_co.40.aspxManagement of delayed encephalopathy after CO poisoning
The addition of dexamethasone, N-butylphthalide, or XingZhi-YiNao granules into HBO, or butylphthalide into MSC could achieve better neurological recovery in ...
4.
withpower.com
withpower.com/trial/dexamethasone-hyperbaric-oxygen-for-carbon-monoxide-poisoning-0c42fDexamethasone + 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 Therapy
This 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 Therapy
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 ...
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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