Steroid, Thiamine and Ascorbic Acid for Comatose Out-of-hospital Cardiac Arrest Survivors

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Collaborators: Chung-Ang University; Ewha Womans University; Hanyang University; Samsung Changwon Hospital; Samsung Medical Center; Seoul St. Mary's Hospital; Wonju Severance Christian Hospital; Yeouido St. Mary's Hospital
• Treatments: Ascorbic Acid; Hydrocortisone; Thiamine

Criteria

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).