Steroid, Thiamine and Ascorbic Acid for Comatose Out-of-hospital Cardiac Arrest Survivors (NCT04921189) | Clinical Trial Compass
CompletedPhase 2
Steroid, Thiamine and Ascorbic Acid for Comatose Out-of-hospital Cardiac Arrest Survivors
South Korea160 participantsStarted 2021-12-31
Plain-language summary
The mortality and neurological outcomes among out-of-hospital cardiac arrest survivors have not improved despite the medical advances. The whole body ischemia/reperfusion 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 ischemia/reperfusion injuries among the out-of-hospital cardiac arrest survivors treated with targeted temperature management.
Who can participate
Age range
19 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* An out-of-hospital cardiac arrest survivors treated with targeted temperature management (target between 32 and 36 °C)
* Presumed cardiogenic cause as cardiac arrest
Exclusion Criteria:
* \> 12 hours from cardiac arrest to drug or placebo administration
* previous poor neurological status (Cerebral Performance Categories 3 to 5)
* patients who have set limitations on treatment (e.g. patients with a signed do-not-resuscitate order)
* Patients with an underlying terminal-stage disease without an active treatment plan and those who are not expected to survive to discharge
* patients taking at least 1 g/day of vitamin C or receiving intravenous thiamine prior to enrolment
* patients experiencing cardiac arrest prior to enrolment or who are expected to die within 24 h despite best possible treatment, based on the judgement of medical personnel
* pregnant women
* patients with glucose-6-phosphate dehydrogenase deficiency
* patients with a history of hypersensitivity reactions to the trial drugs
* patients with thalassemia
* patients with hyperoxaluria
* patients with cystinuria
* patients with ongoing gout attacks
* patients diagnosed with oxalate renal stones
* patients who do not voluntarily consent to participate in the trial (directly or by legal proxy).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a combination of steroids, thiamine, and vitamin C in comatose cardiac arrest survivors — has this combination shown any signal of benefit or harm in the results, and what does that mean for my situation?
2Since this was a Phase 2 trial, the main goal was measuring a brain injury marker called neuron-specific enolase rather than proving the treatment works — does my doctor think the findings are strong enough to influence my care, or is this still considered experimental?
3The trial focused specifically on people who were comatose after an out-of-hospital cardiac arrest — how does my own level of consciousness and recovery after cardiac arrest compare to the patients studied here?
4Are there standard-of-care treatments for post-cardiac arrest syndrome that are already proven and might be a better first step for me, before considering anything based on this early-phase research?
5Since the trial is now completed, has my doctor seen any published results or data, and how do those findings compare to what's already being used in post-cardiac arrest care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.