Nebraska Medicine, Hyperbaric Medicine Program, Clarkson Tower
Omaha, Nebraska, 68105, United States
NCT Number: NCT06574048
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.
Trial opening soon.
Get Notified19 year and older
All sexes
Interventional
Phase 1 / Phase 2
Omaha, Nebraska, 68105, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV saline bolus
Other names: nebulized normal saline (NS) placebo
10mg IV Dexamethasone
Other names: Ozurdex, Maxidex, DexPak 10 day, DexPak 6 Day, LoCort, DoubleDex, ReadySharp dexamethasone, DexPak 13 Day, ZonaCort
Time frame: Prior to hospital discharge after HBO therapy is no longer clinically warranted, and post-discharge at 2 weeks, 6 weeks, and 12 weeks.
The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction that assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. The MoCA will be given in person while inpatient and via phone after discharge. Scored 0-30 Normal Cognitive performance 26 and above Mild impairment 18-25 Moderate impairment 10-17 Severe impairment 0-9
Time frame: 6 weeks and 12 weeks post-treatment
Post-treatment phone followup
Contact information is provided by the study sponsor or research team.
Brooklin Zimmerman, MSN
CONTACT
Jeffrey S Cooper, MD
CONTACT
University of Nebraska
Other
Trial of Dexamethasone vs Placebo as an Adjunctive Therapy to Hyperbaric Oxygen Treatment HBO in Patients With Acute Carbon Monoxide Poisoning
Acronym: CODex
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04925297
Carbon Monoxide Poisoning, Chemically-Induced Disorders
Changchun, Jilin, China
View Trial DetailsNCT04975867
Body Temperature Changes, Carbon Monoxide Poisoning
Wŏnju, Gangwon-do, South Korea
View Trial DetailsNCT06811675
Carbon Monoxide Poisoning, Chemically-Induced Disorders
Taichung, Taiwan
View Trial DetailsNCT06198595
Carbon Monoxide Poisoning, Chemically-Induced Disorders
Ankara, Çankaya, Turkey (Türkiye)
View Trial Details