Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy (COHOST)

University of Nebraska

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Carbon Monoxide Poisoning; Carbon Monoxide-induced Parkinsonism; Carbon Monoxide Intoxication; Carbon Monoxide Encephalopathy

Treatments: Drug: Dexamethasone; Drug: saline placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06574048

0564-24-FB

Details and patient eligibility

About

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.

Full description

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.

The control group will receive three HBO treatment sessions plus placebo. The treatment group will receive three HBO treatment sessions plus 10 mg Dexamethasone per day during HBO therapy (minimum of two doses, up to a maximum of five doses if participant stays for longer than three days). After three treatment sessions, the participant will be discharged home barring no other medical complications requiring further hospitalization. In two weeks, participants will return for follow-up testing and evaluation. Continued HBO therapy plus placebo as well as HBO therapy plus steroids for respective group members will be offered if participants are still dealing with CO poisoning sequelae as determined by our outcome measures. In addition, a 6 week and 12 week telephone follow-up will be conducted asking questions regarding memory, emotion, neurologic symptoms.

Enrollment: 20 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute CO poisoning, intentional or non-intentional exposure, receiving HBO treatment during hospitalization
• Age >18 years
• Nebraska Medicine admission

Exclusion criteria

• Mechanical ventilation
• No hospital admission or admission to hospital Critical Care Medicine Service
• Allergy to dexamethasone
• Pre-Existing neurological condition confounding outcome determination

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Hyperbaric Oxygen Therapy with Dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Dexamethasone

Hyperbaric Oxygen Therapy with Placebo (Saline)

Placebo Comparator group

Description:

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:

Drug: saline placebo