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Corticosteroid

Dexamethasone + Hyperbaric Oxygen for Carbon Monoxide Poisoning (COHOST Trial)

Phase 1 & 2

Waitlist Available

Led By Jeffrey S Cooper, MD

Research Sponsored by University of Nebraska

Eligibility Criteria Checklist

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

Must have

Age >18 years

Acute CO poisoning, intentional or non-intentional exposure, receiving HBO treatment during hospitalization

Must not have

Mechanical ventilation

No hospital admission or admission to hospital Critical Care Medicine Service

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to hospital discharge after hbo therapy is no longer clinically warranted, and post-discharge at 2 weeks, 6 weeks, and 12 weeks.

Summary

This trial is investigating whether adding dexamethasone to hyperbaric oxygen therapy can improve neurological outcomes in patients with carbon monoxide poisoning. Carbon monoxide poisoning can lead to long-term neurological issues

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Dexamethasone may cause side effects such as mood swings, increased blood sugar levels, insomnia, and weakened immune response. HBO therapy can result in ear pressure changes or temporary vision alterations.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 years old.

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I am receiving hyperbaric oxygen therapy for carbon monoxide poisoning.

Exclusion Criteria

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

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I am on a mechanical ventilator.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to hospital discharge after hbo therapy is no longer clinically warranted, and post-discharge at 2 weeks, 6 weeks, and 12 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to hospital discharge after hbo therapy is no longer clinically warranted, and post-discharge at 2 weeks, 6 weeks, and 12 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to hospital discharge after hbo therapy is no longer clinically warranted, and post-discharge at 2 weeks, 6 weeks, and 12 weeks. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Montreal Cognitive Assessment (MoCA)

Secondary study objectives

Memory, Emotion, and Neurologic Symptoms

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Cerebrospinal fluid leak

Deep Vein Thrombosis

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Hyperbaric Oxygen Therapy with DexamethasoneExperimental Treatment1 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 Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

0 / 4Eligibility criteria met