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NCT06574048 | NOT YET RECRUITING | Carbon Monoxide Poisoning


Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy
Sponsor:

University of Nebraska

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.

Condition or disease

Carbon Monoxide Poisoning

Carbon Monoxide Intoxication

Carbon Monoxide Encephalopathy

Carbon Monoxide-induced Parkinsonism

Intervention/treatment

saline placebo

Dexamethasone

Phase

PHASE1

PHASE2

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : QUADRUPLE
Masking Description : Pharmacy will provide either saline or 10mg dexamethasone in saline in a masked fashion so that the clinical staff are blinded.
Primary Purpose : TREATMENT
Official Title : Trial of Dexamethasone vs Placebo as an Adjunctive Therapy to Hyperbaric Oxygen Treatment HBO in Patients With Acute Carbon Monoxide Poisoning
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2028-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy

Location Details

NCT06574048


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Locations


Not yet recruiting

United States, Nebraska

Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower

Omaha, Nebraska, United States, 68105

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