Effects of Corticosteroid Use on Restoration of Spontaneo... | NCT06515327

Studies
Effects of Corticosteroid Use on Restoration of Spontaneous Circulation in Cardiac Arrest Patients

NCT06515327

Sponsor

Saglik Bilimleri Universitesi

Status

Not yet recruiting

Last Update Posted

Jul 23, 2024Actual

Enrollment

46Estimated

Phase

Not provided

Conditions

Cardiopulmonary Arrest
Corticosteroids Adverse Reaction

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Estimated

Primary Completion Date

Aug 1, 2025Estimated

Completion Date

Aug 1, 2025Estimated

First Submitted Date

Jul 9, 2024

First Submission Date that Met QC Criteria

Jul 17, 2024

First Posted Date

Jul 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2024

Last Update Posted Date

Jul 23, 2024Actual

Name	Class
Ankara Etlik City Hospital	OTHER_GOV
Etimesgut Military Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Steroid Group		Patients using corticosteroids for any reason before cardiac arrest
Non-Steroid Group		Patients not using corticosteroids and having cardiac arrest

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
return of spontaneous circulation	patients with return of spontaneous circulation within 20 minutes of cardiopulmonary resuscitation	20 minutes after cardiac arrest

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 and above Witnessed cardiac arrest

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients over the age of 18 with witnessed cardiac arrest

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
gulsen akcay, ass. prof.	Contact	+905052874949		gulakcay@yahoo.com.tr
elif hamzacebioglu kayisoglu, specialist	Contact	+905453300679		turkuaz-61@windowslive.com

Overall Officials

Name	Affiliation	Role
gulsen akcay, ass. prof.	ass. prof. of organization	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Etlik City Hospital		Ankara	Yenimahalle	06170	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38254130	Background	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.
36225952

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases