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Not yet recruiting Phase 1/2 NCT06574048

Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy

Phase 1/2 – combined early trial
Conditions: Carbon Monoxide Poisoning Carbon Monoxide Intoxication Carbon Monoxide Encephalopathy Carbon Monoxide-induced Parkinsonism

Sponsor: University of Nebraska

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Overview
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.
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.
Who can participate
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
Interventions
saline placebo
DRUG
Dexamethasone
DRUG
Locations 1
United States (1)
Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower
Omaha , Nebraska
Technical details
Status
Not yet recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
19 Years
Healthy volunteers
No
Start date
01.07.2026
Completion date
01.01.2028
Registry ID
NCT06574048
Source
clinicaltrials.gov
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