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

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.

Conditions

• Out-Of-Hospital Cardiac Arrest
• Postcardiac Arrest Syndrome

Interventions

DRUG

The combined supplement of Ascorbic acid, Thiamine, and Cortisol

The combined administration of 3 drugs will be mixed in a 50 mL 0.9% saline bag respectively and administered through intravenous infusion over 60 min every 12 h for 3 days. 1. Ascorbic acid (Ascorbic acid Inj \[500mg\]®): 50 mg/kg, maximum single dose 3 g, daily dose 6 g 2. Thiamine (Thiamine hcl inj \[50mg\]®): 200 mg 3. Cortisol (Cortisolu inj \[100mg\]®): 100mg (The main exposure was corticosteroid therapy, defined as the use of systemic corticosteroids. But if unavailable, it could be converted to hydrocortisone-equivalent doses (methylprednisolone 1:5, dexamethasone 1:25, prednisolone 1:4).)

DRUG

Placebo

An identical volume of 0.9% saline (150mL) administered through intravenous infusion over 60 min every 12 h for 3 days.

Sponsors & Collaborators

• Seoul St. Mary's Hospital

  collaborator OTHER

• Wonju Severance Christian Hospital

  collaborator OTHER

• Samsung Changwon Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Chung-Ang University

  collaborator OTHER

• Hanyang University

  collaborator OTHER

• Ewha Womans University

  collaborator OTHER

• Hanil General Hospital

  collaborator UNKNOWN

• Asan Medical Center

  lead OTHER

Principal Investigators

• Won Young Kim, PhD · A

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-31

Primary Completion

2024-12-10

Completion

2025-06-09

Countries

• South Korea

Study Locations