Clinical trial NCT06574048: Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy
Official title: Trial of Dexamethasone vs Placebo as an Adjunctive Therapy to Hyperbaric Oxygen Treatment HBO in Patients With Acute Carbon Monoxide Poisoning
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Carbon Monoxide Poisoning
Carbon Monoxide Intoxication
Carbon Monoxide Encephalopathy
Carbon Monoxide-induced Parkinsonism
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Prior to hospital discharge after HBO therapy is no longer clinically warranted, and post-discharge at 2 weeks, 6 weeks, and 12 weeks.
Secondary outcomes:
measure: Memory, Emotion, and Neurologic Symptoms
timeFrame: 6 weeks and 12 weeks post-treatment
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Jeffrey S Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References: