NCT06515327

Brief Summary

We aim to investigate the effects of pre-arrest corticosteroid use for any reason on the time of return of spontaneous circulation in patients experiencing witnessed cardiac arrest, either in-hospital or out-of-hospital. Additionally, we plan to study the effects of corticosteroid use on post-ROSC administration of vasoactive agents, required dosage of vasoactive agents and number of vasoactive agents needed in order to reach targeted blood pressure levels.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

July 9, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 9, 2024

Last Update Submit

July 17, 2024

Conditions

Keywords

Cardiac Arrest, Corticosteroids Use,

Outcome Measures

Primary Outcomes (1)

  • return of spontaneous circulation

    patients with return of spontaneous circulation within 20 minutes of cardiopulmonary resuscitation

    20 minutes after cardiac arrest

Study Arms (2)

Steroid Group

Patients using corticosteroids for any reason before cardiac arrest

Non-Steroid Group

Patients not using corticosteroids and having cardiac arrest

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients over the age of 18 with witnessed cardiac arrest

You may qualify if:

  • Age 18 and above Witnessed cardiac arrest

You may not qualify if:

  • Traumatic cardiac arrest Forensic cases Cardiac arrest secondary to ST-elevation myocardial infarction Patients in whom spontaneous circulation could not be achieved despite cardiopulmonary resuscitation lasting more than 20 minutes Patients with inaccessible past medical records or unknown medication history Patients without identification Unwitnessed cardiac arrest Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (3)

  • Obling LER, Beske RP, Meyer MAS, Grand J, Wiberg S, Mohr T, Damm-Hejmdal A, Forman JL, Frikke-Schmidt R, Folke F, Moller JE, Kjaergaard J, Hassager C. Effect of prehospital high-dose glucocorticoid on hemodynamics in patients resuscitated from out-of-hospital cardiac arrest: a sub-study of the STEROHCA trial. Crit Care. 2024 Jan 22;28(1):28. doi: 10.1186/s13054-024-04808-3.

    PMID: 38254130BACKGROUND
  • Bagate F, Coppens A, Masi P, de Prost N, Carteaux G, Razazi K, Mekontso Dessap A. Cardiac and vascular effects of low-dose steroids during the early phase of septic shock: An echocardiographic study. Front Cardiovasc Med. 2022 Sep 26;9:948231. doi: 10.3389/fcvm.2022.948231. eCollection 2022.

    PMID: 36225952BACKGROUND
  • Ullian ME. The role of corticosteriods in the regulation of vascular tone. Cardiovasc Res. 1999 Jan;41(1):55-64. doi: 10.1016/s0008-6363(98)00230-2. No abstract available.

    PMID: 10325953BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • gulsen akcay, ass. prof.

    ass. prof. of organization

    STUDY DIRECTOR

Central Study Contacts

gulsen akcay, ass. prof.

CONTACT

elif hamzacebioglu kayisoglu, specialist

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 23, 2024

Study Start

August 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

July 23, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations