Cardiopulmonary ArrestNCT06515327
Effects of Corticosteroid Use on Restoration of Spontaneous Circulation in Cardiac Arrest Patients
An observational study of Cardiopulmonary Arrest and Corticosteroids Adverse Reaction, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest, Corticosteroids Adverse Reaction
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Aug 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients over the age of 18 with witnessed cardiac arrest
Who may be able to join
- Age 18 and above Witnessed cardiac arrest
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik City Hospital
Ankara, Yenimahalle, 06170
gulsen akcay, ass. prof., +905052874949, gulakcay@yahoo.com.tr
elif hamzacebioglu kayisoglu, specalist, +905453300679, turkuaz-61@windowslive.com
About this study
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.
Read the 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
- Keywords
- Cardiac Arrest, Corticosteroids Use,
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Steroid Group | Patients using corticosteroids for any reason before cardiac arrest | |
| Non-Steroid Group | Patients not using corticosteroids and having cardiac arrest |
What is being measured
The primary outcome is the main question the study is designed to answer.
return of spontaneous circulation
patients with return of spontaneous circulation within 20 minutes of cardiopulmonary resuscitation
Measured: 20 minutes after cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ArrestStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital, Etimesgut Military Hospital
- Responsible party
- Sponsor
- Investigators
- gulsen akcay, ass. prof., Study director, ass. prof. of organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515327
- Sponsor's protocol ID
- Corticosteroid Cardiac Arrest
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38254130Bagate 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.
PubMed 36225952Ullian 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.
PubMed 10325953
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Corticosteroid Use on Restoration of Spontaneous Circulation in Cardiac Arrest Patients
- ClinicalTrials.gov ID
- NCT06515327
- Acronym / sponsor ID
- Corticosteroid Cardiac Arrest
- Keywords
- Cardiac Arrest, Corticosteroids Use,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital, Etimesgut Military Hospital
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid Group | – | –Patients using corticosteroids for any reason before cardiac arrest |
| Non-Steroid Group | – | –Patients not using corticosteroids and having cardiac arrest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients over the age of 18 with witnessed cardiac arrest
Key inclusion criteria (1 listed)
- Age 18 and above Witnessed cardiac arrest
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
return of spontaneous circulation
Time frame: 20 minutes after cardiac arrest
patients with return of spontaneous circulation within 20 minutes of cardiopulmonary resuscitation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 38254130Obling 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.
- Background: PubMed 36225952Bagate 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.
- Background: PubMed 10325953Ullian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
gulsen akcay, ass. prof. study director
ass. prof. of organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Arrest and Corticosteroids Adverse Reaction, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gulsen akcay, ass. prof. (+905052874949, gulakcay@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
return of spontaneous circulation (time frame: 20 minutes after cardiac arrest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515327, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.