Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04921189
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2021-06-04
Brief Title:
Steroid Thiamine and Ascorbic Acid for Comatose Out-of-hospital Cardiac Arrest Survivors
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Steroid Thiamine and Ascorbic Acid During Post-Resuscitation Period for Comatose Out-of-hospital Cardiac Arrest Survivors STAR Trial Multi-center Randomized Single-blinded Controlled Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The mortality and neurological outcomes among out-of-hospital cardiac arrest survivors have not improved despite the medical advances The whole body ischemiareperfusion injuries after cardiac arrest mainly damaged the brain To improve the neurologic outcome among those patients additional interventions would be warranted
The investigators hypothesize that the combined use of cortisol ascorbic acid vitamin C and thiamine during the early post-resuscitation period would attenuate the whole-body ischemiareperfusion injuries among the out-of-hospital cardiac arrest survivors treated with targeted temperature management
The investigators hypothesize that the combined use of cortisol ascorbic acid vitamin C and thiamine during the early post-resuscitation period would attenuate the whole-body ischemiareperfusion injuries among the out-of-hospital cardiac arrest survivors treated with targeted temperature management
Detailed Description:
The mortality and neurological outcomes among the out-of-hospital cardiac arrest survivors are still dismal In addition the metabolic and oxidative stress can persist or even worsen at the cellular level after resuscitation and these whole-body ischemiareperfusion injuries contribute to multiple organ failure known as the post-cardiac arrest syndrome Therefore additional interventions to reduces the injuries would be warranted
Cortisol has beneficial antioxidant and anti-apoptotic properties and stabilizes cellular membranes exposed to oxidative stress It also maintains hemodynamic stability and improves organ function by reducing ischemiareperfusion injuries
Thiamine is a cofactor that acts on enzymes essential for glucose metabolism the generation of adenosine triphosphate and nicotinamide adenine dinucleotide phosphate production It assists the cellular metabolisms and attenuates the potential adverse effect of ascorbic acid vitamin C by preventing the conversion of ascorbic acid into oxalate Ascorbic acid is a well-known antioxidant and has anti-inflammatory effects It acted as an antioxidant defense substance reducing reactive oxygen species and reactive nitrogen species and improving microcirculation by limiting oxidative injury and endothelial barrier disruption The theoretical and experimental studies suggested the concomitant use of cortisol thiamine and ascorbic acid might have potential treatment synergism for whole-body ischemiareperfusion injuries after cardiac arrest
The investigators hypothesize that their combined use during the early post-resuscitation period will reduce the whole-body ischemiareperfusion injuries especially the brain in out-of-hospital cardiac arrest survivors treated with targeted temperature management
Cortisol has beneficial antioxidant and anti-apoptotic properties and stabilizes cellular membranes exposed to oxidative stress It also maintains hemodynamic stability and improves organ function by reducing ischemiareperfusion injuries
Thiamine is a cofactor that acts on enzymes essential for glucose metabolism the generation of adenosine triphosphate and nicotinamide adenine dinucleotide phosphate production It assists the cellular metabolisms and attenuates the potential adverse effect of ascorbic acid vitamin C by preventing the conversion of ascorbic acid into oxalate Ascorbic acid is a well-known antioxidant and has anti-inflammatory effects It acted as an antioxidant defense substance reducing reactive oxygen species and reactive nitrogen species and improving microcirculation by limiting oxidative injury and endothelial barrier disruption The theoretical and experimental studies suggested the concomitant use of cortisol thiamine and ascorbic acid might have potential treatment synergism for whole-body ischemiareperfusion injuries after cardiac arrest
The investigators hypothesize that their combined use during the early post-resuscitation period will reduce the whole-body ischemiareperfusion injuries especially the brain in out-of-hospital cardiac arrest survivors treated with targeted temperature management
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None