Cardiac Arrest, SuddenNCT04786860
The Success Rate of Cardiopulmonary Resuscitation in Patients Experiencing In-hospital Cardiac Arrest
An observational study of Cardiac Arrest, Sudden and Cardiopulmonary Arrest, run by Udayana University at 2 sites in Indonesia.
Trial summary
Cardiac arrest causes the heart to stop functioning to maintain circulation that provides oxygen to the brain. The global incidence of cardiac arrest is 50 to 60 per 100,000 people per year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Sudden, Cardiopulmonary Arrest, Cardiopulmonary Failure
- What is being tested?
- CPR
- Type of treatment
- Surgery or procedure
- How many people
- 415 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 Nov 2021to 31 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients
Who may be able to join
- Patients with in-hospital cardiac arrest that were treated at Sanglah General Hospital
Who cannot join
- Patients who upon admission to the hospital already showing cardiac arrest rhythm
- Patients who were DOA (death-on-arrival)
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Prof. Ngoerah General Hospital
Denpasar, Bali, 80114
Sanglah General Hospital
Denpasar, Bali, 80114
About this study
Official title: The Success Rate of Cardiopulmonary Resuscitation in Patients Experiencing In-hospital Cardiac Arrest at Sanglah General Hospital
Cardiac arrest causes the heart to stop functioning to maintain circulation that provides oxygen to the brain. The global incidence of cardiac arrest is 50 to 60 per 100,000 people per year. The incidence of cardiac arrest in Indonesia in 2016 was 350,000 cases, in which 12% were successfully resuscitated, compared to the global success rate of 24.8%.
Cardiac arrest events urgently require CPR action that is useful to save lives in an emergency. The application of Code Blue aims to reduce the mortality rate and increase the rate of return of spontaneous circulation. The Code Blue team itself includes a set of teams who are trained in the handling of cardiorespiratory arrest.
- Conditions
- Cardiac Arrest, Sudden, Cardiopulmonary Arrest, Cardiopulmonary Failure, In-hospital Cardiac Arrest
- Being tested
- CPR
- Keywords
- in-hospital, cardiac arrest, resuscitation, success rate
- Medical subject headings
- Death, Sudden, Cardiac, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPRProcedure or surgery
Cardiopulmonary resuscitation performed on patients with in-hospital cardiac arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivors
The number of patients who were successfully converted to ROSC (return of spontaneous circulation)
Measured: 6-hours after CPR is stopped
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Nov 2021
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, SuddenStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Ryalino, MD, Udayana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786860
- Sponsor's protocol ID
- UNUD-CTR-FK210321-001
- Status last verified
- Apr 2024
- First submitted
- 3 Mar 2021
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Success Rate of Cardiopulmonary Resuscitation in Patients Experiencing In-hospital Cardiac Arrest at Sanglah General Hospital
- ClinicalTrials.gov ID
- NCT04786860
- Acronym / sponsor ID
- UNUD-CTR-FK210321-001
- Conditions
- Cardiac Arrest, Sudden, Cardiopulmonary Arrest, Cardiopulmonary Failure, In-hospital Cardiac Arrest
- Keywords
- in-hospital, cardiac arrest, resuscitation, success rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Mar 2021 (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.
Cardiac arrest causes the heart to stop functioning to maintain circulation that provides oxygen to the brain. The global incidence of cardiac arrest is 50 to 60 per 100,000 people per year. The incidence of cardiac arrest in Indonesia in 2016 was 350,000 cases, in which 12% were successfully resuscitated, compared to the global success rate of 24.8%.
Cardiac arrest events urgently require CPR action that is useful to save lives in an emergency. The application of Code Blue aims to reduce the mortality rate and increase the rate of return of spontaneous circulation. The Code Blue team itself includes a set of teams who are trained in the handling of cardiorespiratory arrest.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients
Key inclusion criteria (1 listed)
- Patients with in-hospital cardiac arrest that were treated at Sanglah General Hospital
Key exclusion criteria (2 listed)
- Patients who upon admission to the hospital already showing cardiac arrest rhythm
- Patients who were DOA (death-on-arrival)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPRCardiopulmonary resuscitation performed on patients with in-hospital cardiac arrest | Procedure or surgery | – |
Primary outcome
Survivors
Time frame: 6-hours after CPR is stopped
The number of patients who were successfully converted to ROSC (return of spontaneous circulation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, Sudden and Cardiopulmonary Arrest, run by Udayana University at 2 sites in Indonesia.
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 2 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survivors (time frame: 6-hours after CPR is stopped). 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 16 Apr 2024.