Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574048
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Carbon Monoxide Hyperbaric Oxygen With Steroid Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Trial of Dexamethasone vs Placebo as an Adjunctive Therapy to Hyperbaric Oxygen Treatment HBO in Patients With Acute Carbon Monoxide Poisoning
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COHOST
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None