NCT04921189

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

December 31, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

2.9 years

First QC Date

June 4, 2021

Last Update Submit

June 8, 2025

Conditions

Out-Of-Hospital Cardiac ArrestPostcardiac Arrest Syndrome

Keywords

Postcardiac Arrest SyndromeIschemia/reperfusion injuryNeuron-specific enolaseAscorbic acidThiamineCortisol

Outcome Measures

Primary Outcomes (1)

  • the peak neuron-specific enolase level

    Serum Neuron-Specific Enolase (NSE) level at 48 to 72 hours after resuscitation will measured by enzyme immunoassay, respectively. We will use the peak neuron-specific enolase level.

    48 to 72 hours

Secondary Outcomes (14)

  • the delta neuron-specific enolase (NSE) level

    at 48, 72 hours

  • The delta Sequential Organ Failure Assessment (SOFA) score

    at 24, 48, 72 hours

  • 30-day Mortality

    30 days

  • Time to death

    30 days

  • In-hospital mortality

    1 year

  • +9 more secondary outcomes

Study Arms (2)

The combined supplement of Ascorbic acid, Thiamine, and Cortisol

ACTIVE COMPARATOR

The combined administration of 3 drugs will be administered through intravenous infusion over 60 min every 12 h for 3 days for the out-of-hospital cardiac arrest survivors treated with targeted temperature management.

Drug: The combined supplement of Ascorbic acid, Thiamine, and Cortisol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

The combined supplement of Ascorbic acid, Thiamine, and CortisolDRUG

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).)

Also known as: Ascorbic acid, Thiamine hcl, Cortisolu
The combined supplement of Ascorbic acid, Thiamine, and Cortisol
PlaceboDRUG

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

Also known as: Normal saline
Placebo

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • An out-of-hospital cardiac arrest survivors treated with targeted temperature management (target between 32 and 36 °C)
  • Presumed cardiogenic cause as cardiac arrest

You may not qualify if:

  • \> 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (1)

  • Kim YJ, Ko BS, Roh YI, Kim YH, Kim WY. Steroid, thiamine, and ascorbic acid during post-resuscitation period for comatose out-of-hospital cardiac arrest survivors (STAR) trial: Protocol for a clinical trial. PLoS One. 2025 Apr 11;20(4):e0319733. doi: 10.1371/journal.pone.0319733. eCollection 2025.

    PMID: 40215244DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestPost-Cardiac Arrest SyndromeReperfusion Injury

Interventions

ThiamineHydrocortisoneAscorbic AcidSaline Solution

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Won Young Kim, PhD

    A

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 10, 2021

Study Start

December 31, 2021

Primary Completion

December 10, 2024

Study Completion

June 9, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)