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Steroid, thiamine, and ascorbic acid for comatose out-of-hospital cardiac arrest survivors (STAR): a randomised, placebo-controlled, phase 2 trial.

Overview

Authors: Youn-Jung Kim1, Byuk Sung Ko2, Young-Il Roh3, Hyo Jeong Kwon1, Seonok Kim4, Kyoung-Chul Cha3, Yong Hwan Kim5, Won Young Kim1
ORCID iDs: Youn-Jung Kim, Seonok Kim, Kyoung-Chul Cha, Won Young Kim
  1. Department of Emergency Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
  2. Department of Emergency Medicine, College of Medicine, Hanyang University, Seoul, South Korea
  3. Department of Emergency Medicine, Yonsei University Wonju College of Medicine, Wonju, South Korea
  4. Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
  5. Department of Emergency Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, South Korea
Institutions: Asan Medical Center (South Korea); University of Ulsan (South Korea); Samsung Changwon Hospital (South Korea); Sungkyunkwan University (South Korea); Hanyang University (South Korea); Yonsei University (South Korea)
Journal: EClinicalMedicine, volume 100, article 104191
Dates: received 18 May 2026; accepted 21 August 2026; published online 5 September 2026
Type: Research article · Language: English
License: CC BY-NC
Identifiers: DOI 10.1016/j.eclinm.2026.104191 · PMID 42733931 · PMCID PMC13571931 · OpenAlex W7208838337
Open access: gold, a free copy (OpenAlex)
Status: code on request
Categories: human (organism), clinical / translational (subfield)
Methods: Statistics
Keywords: Out-of-hospital cardiac arrest, Neuroprotection, Neuron-specific enolase, Hydrocortisone, Ascorbic acid, Thiamine
Topic: Cardiac Arrest and Resuscitation (Emergency Medicine, Medicine), according to OpenAlex
Funding: Korea Health Industry Development Institute (RS-2024–00335934); National Research Foundation of Korea (NRF-2021R1A2C2014304)
Citations: not cited yet (Europe PMC); 30 references in the paper

Abstract

Background: Pharmacologic neuroprotection for out-of-hospital cardiac arrest (OHCA) remains elusive. We evaluated whether early hydrocortisone, ascorbic acid, and thiamine reduced neuronal injury in comatose OHCA survivors.

Methods: In this multicentre, placebo-controlled trial across four South Korean hospitals, comatose adult OHCA survivors undergoing targeted temperature management were randomly assigned (1:1) to intravenous hydrocortisone (100 mg), ascorbic acid (50 mg/kg), and thiamine (200 mg) every 12 h for 3 days, or placebo. Randomisation was computer-generated. Bedside clinicians were aware of treatment allocation, whereas laboratory personnel and independent outcome assessors were masked. The primary outcome was peak neuron-specific enolase (NSE) concentration, defined as the highest available value measured at 48 h or 72 h after return of spontaneous circulation. Efficacy was analysed using a modified intention-to-treat (mITT) principle, with multiple imputation for the full intention-to-treat (ITT) population. The completed trial was registered with ClinicalTrials.gov on June 4, 2021 (NCT04921189).

Findings: Between Dec 31, 2021, and Dec 7, 2024, 160 participants (123 male, 37 female) were assigned (80 per group); 147 were included in the mITT analysis (74 treatment, 73 placebo). Peak NSE levels were 47·4 ng/mL (interquartile range [IQR] 22·4–262·6) in the treatment group and 53·3 ng/mL (IQR 26·6–244·2) in the placebo group (median difference −5·9 ng/mL; 95% confidence interval [CI] −34·5–40·8; p = 0·54). ITT sensitivity findings were consistent (geometric mean ratio 0·94; 95% CI 0·61–1·46; p = 0·80). At 180 days, survival (63·5% vs 69·9%) and good neurological outcome (54·1% vs 56·2%) were similar. Serious adverse events were comparable in the ITT population (52·5% vs 50·0%), with none deemed related to the study medication.

Interpretation: Early administration of hydrocortisone, ascorbic acid, and thiamine did not reduce neuronal injury or improve 6-month clinical outcomes. The findings do not support empiric neuroprotective use in comatose OHCA survivors.

Funding: National Research Foundation of Korea and Korea Health Technology R&D Project.

Reproduced under the paper's license (CC BY-NC), from the paper cited above.

Code

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Data

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Data sharing statement

Deidentified individual participant data, along with a data dictionary defining each field and the statistical code used for the analysis, will be made available upon reasonable request. Additional related documents, including the study protocol and statistical analysis plan, will also be available. These data will be shared with researchers who provide a methodologically sound proposal for the purpose of individual participant data meta-analysis. Data will be available beginning with publication and ending 5 years following publication. To gain access, data requestors will need to sign a data access agreement. Requests should be directed to the corresponding author at .

Reproduced under the paper's license (CC BY-NC), from the paper cited above.

Versions

The history of this record: each version stored by the harvester or made by a correction of its authors or of the maintainers of its code, and what changed in its facts. The texts of the paper (its abstract, its availability statements) are not part of it; versions that changed only those are not listed.

Version 3, 28 September 2026

  • Authors: added Youn-Jung Kim (0000-0003-1385-5836); Seonok Kim (0000-0001-9010-5460); Kyoung-Chul Cha (0000-0003-1818-2466); Won Young Kim (0000-0002-6904-5966); removed Youn-Jung Kim; Seonok Kim; Kyoung-Chul Cha; Won Young Kim
  • Funding: added Korea Health Industry Development Institute: RS-2024–00335934; National Research Foundation of Korea: NRF-2021R1A2C2014304

Version 1, 27 September 2026: the first record

Recorded: type, language, journal, volume, pages, dates, 8 authors, 6 keywords, 29 references.

Cite

This paper

Kim, Y.-J., Ko, B. S., Roh, Y.-I., Kwon, H. J., Kim, S., Cha, K.-C., Kim, Y. H., & Kim, W. Y. (2026). Steroid, thiamine, and ascorbic acid for comatose out-of-hospital cardiac arrest survivors (STAR): a randomised, placebo-controlled, phase 2 trial. EClinicalMedicine, 100, 104191. https://doi.org/10.1016/j.eclinm.2026.104191

BibTeX

@article{kim2026steroid,
author = {Kim, Youn-Jung and Ko, Byuk Sung and Roh, Young-Il and Kwon, Hyo Jeong and Kim, Seonok and Cha, Kyoung-Chul and Kim, Yong Hwan and Kim, Won Young},
title = {{Steroid, thiamine, and ascorbic acid for comatose out-of-hospital cardiac arrest survivors (STAR): a randomised, placebo-controlled, phase 2 trial}},
journal = {EClinicalMedicine},
year = {2026},
month = sep,
volume = {100},
pages = {104191},
publisher = {Elsevier},
issn = {2589-5370},
doi = {10.1016/j.eclinm.2026.104191},
url = {https://doi.org/10.1016/j.eclinm.2026.104191},
pmid = {42733931},
pmcid = {PMC13571931}
}

RIS

TY - JOUR
AU - Kim, Youn-Jung
AU - Ko, Byuk Sung
AU - Roh, Young-Il
AU - Kwon, Hyo Jeong
AU - Kim, Seonok
AU - Cha, Kyoung-Chul
AU - Kim, Yong Hwan
AU - Kim, Won Young
TI - Steroid, thiamine, and ascorbic acid for comatose out-of-hospital cardiac arrest survivors (STAR): a randomised, placebo-controlled, phase 2 trial
T2 - EClinicalMedicine
J2 - eClinicalMedicine
PY - 2026
DA - 2026/09/05
VL - 100
SP - 104191
SN - 2589-5370
PB - Elsevier
DO - 10.1016/j.eclinm.2026.104191
UR - https://doi.org/10.1016/j.eclinm.2026.104191
LA - en
ER -

CSL-JSON

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