Post-Resuscitation SyndromePROM-ROSCNCT07020091
Predicting Mortality in Patients With Return of Spontaneous Circulation After Cardiac Arrest
An observational study of Post-Resuscitation Syndrome and Critical Illness, run by Ahmet Düzgün at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational cohort study aims to identify early predictors of short- and mid-term mortality in adult patients who achieved return of spontaneous circulation (ROSC) after cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Resuscitation Syndrome, Critical Illness, Cardiac Arrest
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years old) who achieved return of spontaneous circulation (ROSC) after cardiac arrest and were admitted to the intensive care unit (ICU) at Gazi Yaşargil Training and Research Hospital, Turkey. Patients are consecutively enrolled and observed for outcomes related to in-hospital and 6-month mortality.
Who may be able to join
- Age ≥ 18 years
- Achieved return of spontaneous circulation (ROSC) after cardiac arrest
- Admitted to the intensive care unit (ICU)
- Informed consent obtained from patient or legal representative (if applicable)
Who cannot join
- Age < 18 years
- Known pregnancy
- Brain death at the time of ICU admission
- Patients with missing key clinical or laboratory data
- Declined participation or legal refusal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi Yaşargil Training and Research Hospital
Diyarbakır, Kayapinar, 21070
About this study
Official title: Predictors of In-Hospital Mortality in Patients With Return of Spontaneous Circulation After Cardiac Arrest: A Retrospective Observational Cohort Study
This retrospective observational cohort study aims to identify early predictors of short- and mid-term mortality in adult patients who achieved return of spontaneous circulation (ROSC) after cardiac arrest. Eligible patients admitted to the intensive care unit between January 1, 2024 and May 31, 2025 were identified retrospectively from electronic medical records following institutional ethics approval. Clinical, biochemical, and resuscitation-related parameters recorded within the first 24 hours of ICU admission were analyzed. The primary objective was to determine factors independently associated with short-term mortality. Six-month mortality was additionally assessed using hospital records and the national death registry. The findings are expected to improve risk stratification and clinical decision-making in post-cardiac arrest care.
Read the detailed description
This retrospective observational cohort study was conducted in the intensive care unit (ICU) of Gazi Yaşargil Training and Research Hospital, Turkey. Adult patients (≥18 years) who achieved return of spontaneous circulation (ROSC) after cardiac arrest and were admitted to the ICU between January 1, 2024 and May 31, 2025 were identified retrospectively from electronic medical records following institutional ethics approval.
Baseline demographic, clinical, laboratory, and resuscitation-related variables recorded within the first 24 hours of ICU admission were extracted from hospital records. These variables included arrest characteristics, time to ROSC, initial rhythm, hemodynamic parameters, neurological status, laboratory biomarkers, and therapeutic interventions routinely performed in ICU practice.
The primary outcome was 30-day all-cause mortality. Secondary outcomes included 24-hour, 7-day, and 6-month mortality, neurological outcome at hospital discharge, and ICU length of stay. Six-month mortality status was confirmed using hospital records and the national death registry.
A total of 168 eligible patients were identified during the study period. Multivariate logistic regression analysis was performed to identify independent predictors of mortality. No interventions beyond routine clinical care were conducted.
- Conditions
- Post-Resuscitation Syndrome, Critical Illness, Cardiac Arrest, Hypoxic-Ischemic Encephalopathy, Coma
- Keywords
- Cardiac Arrest, ROSC, In-Hospital Mortality, ICU, Post-Resuscitation Care, Neurological Outcome
- Medical subject headings
- Critical Illness, Heart Arrest, Hypoxia-Ischemia, Brain, Coma
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 |
|---|---|---|
| ROSC Cohort | Adult patients (≥18 years old) who achieved return of spontaneous circulation (ROSC) after cardiac arrest and were admitted to the intensive care unit. These patients are prospectively followed to evaluate clinical and biochemical predictors of in-hospital mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Mortality
All-cause mortality within 30 days of ICU admission following ROSC.
Measured: 30 days after ICU admission
Secondary outcomes (2)
In-Hospital Mortality
All-cause mortality recorded during the index hospital stay following return of spontaneous circulation (ROSC).
Measured: From ICU admission to hospital discharge (up to 60 days)
6-Month Mortality
All-cause mortality assessed at 6 months following the initial cardiac arrest event. Mortality status is confirmed through hospital records and national death registry.
Measured: 6 months after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post-Resuscitation SyndromeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmet Düzgün
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmet Düzgün, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020091
- Sponsor's protocol ID
- GAZI-494-ROSC-2025
- Other IDs
- GAZI-ROSC-494-2025
- Acronym
- PROM-ROSC
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2025
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, no final decision has been made regarding individual participant data (IPD) sharing. The possibility of sharing anonymized IPD will be evaluated after the study is completed and initial results are published, taking into account ethical, legal, and institutional considerations.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of In-Hospital Mortality in Patients With Return of Spontaneous Circulation After Cardiac Arrest: A Retrospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07020091
- Acronym / sponsor ID
- PROM-ROSC / GAZI-494-ROSC-2025
- Conditions
- Post-Resuscitation Syndrome, Critical Illness, Cardiac Arrest, Hypoxic-Ischemic Encephalopathy, Coma
- Keywords
- Cardiac Arrest, ROSC, In-Hospital Mortality, ICU, Post-Resuscitation Care, Neurological Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Ahmet DüzgünUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Posted 8 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This retrospective observational cohort study aims to identify early predictors of short- and mid-term mortality in adult patients who achieved return of spontaneous circulation (ROSC) after cardiac arrest. Eligible patients admitted to the intensive care unit between January 1, 2024 and May 31, 2025 were identified retrospectively from electronic medical records following institutional ethics approval. Clinical, biochemical, and resuscitation-related parameters recorded within the first 24 hours of ICU admission were analyzed. The primary objective was to determine factors independently associated with short-term mortality. Six-month mortality was additionally assessed using hospital records and the national death registry. The findings are expected to improve risk stratification and clinical decision-making in post-cardiac arrest care.
Detailed description
This retrospective observational cohort study was conducted in the intensive care unit (ICU) of Gazi Yaşargil Training and Research Hospital, Turkey. Adult patients (≥18 years) who achieved return of spontaneous circulation (ROSC) after cardiac arrest and were admitted to the ICU between January 1, 2024 and May 31, 2025 were identified retrospectively from electronic medical records following institutional ethics approval.
Baseline demographic, clinical, laboratory, and resuscitation-related variables recorded within the first 24 hours of ICU admission were extracted from hospital records. These variables included arrest characteristics, time to ROSC, initial rhythm, hemodynamic parameters, neurological status, laboratory biomarkers, and therapeutic interventions routinely performed in ICU practice.
The primary outcome was 30-day all-cause mortality. Secondary outcomes included 24-hour, 7-day, and 6-month mortality, neurological outcome at hospital discharge, and ICU length of stay. Six-month mortality status was confirmed using hospital records and the national death registry.
A total of 168 eligible patients were identified during the study period. Multivariate logistic regression analysis was performed to identify independent predictors of mortality. No interventions beyond routine clinical care were conducted.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ROSC Cohort | – | –Adult patients (≥18 years old) who achieved return of spontaneous circulation (ROSC) after cardiac arrest and were admitted to the intensive care unit. These patients are prospectively followed to evaluate clinical and biochemical predictors of in-hospital mortality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) who achieved return of spontaneous circulation (ROSC) after cardiac arrest and were admitted to the intensive care unit (ICU) at Gazi Yaşargil Training and Research Hospital, Turkey. Patients are consecutively enrolled and observed for outcomes related to in-hospital and 6-month mortality.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Achieved return of spontaneous circulation (ROSC) after cardiac arrest
- Admitted to the intensive care unit (ICU)
- Informed consent obtained from patient or legal representative (if applicable)
Key exclusion criteria (5 listed)
- Age < 18 years
- Known pregnancy
- Brain death at the time of ICU admission
- Patients with missing key clinical or laboratory data
- Declined participation or legal refusal
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
30-Day Mortality
Time frame: 30 days after ICU admission
All-cause mortality within 30 days of ICU admission following ROSC.
2 secondary outcomes
In-Hospital Mortality
Time frame: From ICU admission to hospital discharge (up to 60 days)
6-Month Mortality
Time frame: 6 months after ICU admission
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. At this stage, no final decision has been made regarding individual participant data (IPD) sharing. The possibility of sharing anonymized IPD will be evaluated after the study is completed and initial results are published, taking into account ethical, legal, and institutional considerations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Post-Resuscitation Syndrome and Critical Illness, run by Ahmet Düzgün 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 8 May 2026. 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?
Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-Day Mortality (time frame: 30 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.