- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06515327
Effects of Corticosteroid Use on Restoration of Spontaneous Circulation in Cardiac Arrest Patients
Study Overview
Status
Detailed Description
Patients will be collected from Etlik City Hospital Emergency Medicine Department. Patients presenting with witnessed cardiac arrest, either in-hospital or out-of-hospital, will be enrolled in our study.
Inclusion Criteria:
Age 18 and above Witnessed cardiac arrest
Exclusion Criteria:
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
Patients will be divided into two groups:
The first group will consist of 23 patients who used corticosteroid medications for any reason before experiencing cardiac arrest.
The second group will consist of 23 patients who did not use corticosteroid medications before cardiac arrest.
Following successful cardiopulmonary resuscitation and restoration of spontaneous circulation, the following parameters will be recorded for both groups: need for vasopressor support, number of vasopressor agents used, maximum dose of vasopressor agent(s) required to maintain mean arterial pressure (MAP) >65 mmHg, duration of stay in intensive care unit/emergency department, mortality rate, length of hospital stay, patients' medical histories, age, and gender.
These parameters will be compared between the corticosteroid-using and non-using groups, and statistical analysis will be conducted to evaluate differences between the two groups
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Gulsen AKCAY, Ass. Prof.
- Phone Number: +905052874949
- Email: gulakcay@yahoo.com.tr
Study Contact Backup
- Name: Elif HAMZACEBIOGLU KAYISOGLU, Specialist
- Phone Number: +905453300679
- Email: turkuaz-61@windowslive.com
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey, 06170
- Etlik City Hospital
-
Contact:
- Gulsen AKCAY, Ass. Prof.
- Phone Number: +905052874949
- Email: gulakcay@yahoo.com.tr
-
Principal Investigator:
- gulsen akcay, ass. prof
-
Sub-Investigator:
- bedriye muge sonmez, ass.prof.
-
Contact:
- elif hamzacebioglu kayisoglu, specalist
- Phone Number: +905453300679
- Email: turkuaz-61@windowslive.com
-
Sub-Investigator:
- elif hamzacebioglu kayisoglu, specialist
-
Sub-Investigator:
- Murat OZDEMIR, specialist
-
Sub-Investigator:
- tayyar apa, resident
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Age 18 and above Witnessed cardiac arrest
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Steroid Group
Patients using corticosteroids for any reason before cardiac arrest
|
|
Non-Steroid Group
Patients not using corticosteroids and having cardiac arrest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
return of spontaneous circulation
Time Frame: 20 minutes after cardiac arrest
|
patients with return of spontaneous circulation within 20 minutes of cardiopulmonary resuscitation
|
20 minutes after cardiac arrest
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: gulsen akcay, ass. prof., ass. prof. of organization
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Corticosteroid Cardiac Arrest
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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