Cardiopulmonary ResuscitationNCT03597425
Prognostic Indicators of Survival Following Cardiopulmonary Resuscitation in Patients With Cardiac Arrest
An observational study of Cardiopulmonary Resuscitation, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Cardiopulmonary resuscitation (CPR) occurs approximately 200,000 times/yr in hospitals in the UnitedStates, with 18% of patients surviving to discharge. Just over half of these survivors are neurologically intact or with mild defiits at the time of discharge. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiopulmonary Resuscitation
- What is being tested?
- Cardiopulmonary resuscitation
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jan 2020
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: patients with cardiac arrest
Who may be able to join
- age more than 18 years,
- sudden arrest with potentially reversible causes,
- a short no fow time (time interval from presumed arrest to CPR initiation)
- even for unwitnessed arrests
Who cannot join
- presence of a terminal illness or malignancy, severe irreversible neurologic defcit,
- suspected or confrmed traumatic origin of arrest,
- no informed consent from the family
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Genglong Liu
Shunde, Guangdong
Genglong Liu, MD, +8615626405844, lglong3@mail2.sysu.edu.cn
About this study
Official title: Prognostic Indicators of Survival Following Cardiopulmonary Resuscitation in Patients With Cardiac Arrest: a Single-institutional Study
Cardiopulmonary resuscitation (CPR) occurs approximately 200,000 times/yr in hospitals in the UnitedStates, with 18% of patients surviving to discharge. Just over half of these survivors are neurologically intact or with mild defiits at the time of discharge. Do-not-resuscitate (DNR) orders are used to withhold CPR from patients who are unlikely to benefi or for whom it is inconsistent with their treatment goals or personal preferences. It would be helpful to identify patients with a very low likelihood of survival to discharge neurologically intact or with mild defiits were they to experience cardiopulmonary arrest (CPA), so their physician can present the option of a DNR order. This information would also be useful anytime a patient raises the question of the likelihood of survival should they undergo CPA.The objective of this study was to determine key indicators for good outcome in patients with sudden cardiac arrest undergoing CPR and develop a prediction model to predict survival to hospital discharge in these patients.
Read the detailed description
A CPR coordinator prospectively collected data for the CPR registry according to the Utstein-style guidelines. Te registry included the following information:
demographic data, comorbidities, whether the arrest was witnessed, the incidence of suspected or confrmed trauma, presumed arrest time; presence of bystander CPR, frst documented arrest rhythm by the emergency medical service (EMS) provider, any return of spontaneous circulation (ROSC), presence of ECPR, the presence of return of spontaneous heart beating (ROSB) after CPR, presumed cause of arrest; the application of therapeutic hypothermia and the use of coronary angiography(CAG) or percutaneous coronary intervention (PCI),24-hour survival, the presence of ROSC more than 20 min, hospital length of stay (LOS), survival to hospital discharge,Glasgow-Pittsburgh cerebral performance category (CPC) score at discharge, and the fnal diagnosis at discharge. Te comorbidity score was calculated using the Charlson comorbidity index. Te duration of CPR was defned as the time interval from the frst chest compression provided by healthcare providers to the termination of resuscitation eforts due to ROSC (more than 20 min),ROSB after CPR, or a declaration of death. A favorable neurologic outcome was defned as a CPC score of 1 or 2 on the fve-category scale.
- Conditions
- Cardiopulmonary Resuscitation
- Being tested
- Cardiopulmonary resuscitation
- Keywords
- Cardiac arrest, Cardiopulmonary resuscitation, Survival, Prediction
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary resuscitationProcedure or surgery
Cardiopulmonary resuscitation (CPR) is an emergency treatment for patients with respiratory arrest and cardiac arrest in an attempt to restore the patient to spontaneous breathing and heartbeat through cardiopulmonary resuscitation
What is being measured
The primary outcome is the main question the study is designed to answer.
indicators of survival
The survival outcome was analyzed with logstic regression
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start1 Jan 2017
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GengLong Liu, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Genglong Liu, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597425
- Sponsor's protocol ID
- cardiopulmonary resuscitation
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 24 Jul 2018
- 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 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Indicators of Survival Following Cardiopulmonary Resuscitation in Patients With Cardiac Arrest: a Single-institutional Study
- ClinicalTrials.gov ID
- NCT03597425
- Acronym / sponsor ID
- cardiopulmonary resuscitation
- Conditions
- Cardiopulmonary Resuscitation
- Keywords
- Cardiac arrest, Cardiopulmonary resuscitation, Survival, Prediction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 24 Jul 2018 (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.
Cardiopulmonary resuscitation (CPR) occurs approximately 200,000 times/yr in hospitals in the UnitedStates, with 18% of patients surviving to discharge. Just over half of these survivors are neurologically intact or with mild defiits at the time of discharge. Do-not-resuscitate (DNR) orders are used to withhold CPR from patients who are unlikely to benefi or for whom it is inconsistent with their treatment goals or personal preferences. It would be helpful to identify patients with a very low likelihood of survival to discharge neurologically intact or with mild defiits were they to experience cardiopulmonary arrest (CPA), so their physician can present the option of a DNR order. This information would also be useful anytime a patient raises the question of the likelihood of survival should they undergo CPA.The objective of this study was to determine key indicators for good outcome in patients with sudden cardiac arrest undergoing CPR and develop a prediction model to predict survival to hospital discharge in these patients.
Detailed description
A CPR coordinator prospectively collected data for the CPR registry according to the Utstein-style guidelines. Te registry included the following information:
demographic data, comorbidities, whether the arrest was witnessed, the incidence of suspected or confrmed trauma, presumed arrest time; presence of bystander CPR, frst documented arrest rhythm by the emergency medical service (EMS) provider, any return of spontaneous circulation (ROSC), presence of ECPR, the presence of return of spontaneous heart beating (ROSB) after CPR, presumed cause of arrest; the application of therapeutic hypothermia and the use of coronary angiography(CAG) or percutaneous coronary intervention (PCI),24-hour survival, the presence of ROSC more than 20 min, hospital length of stay (LOS), survival to hospital discharge,Glasgow-Pittsburgh cerebral performance category (CPC) score at discharge, and the fnal diagnosis at discharge. Te comorbidity score was calculated using the Charlson comorbidity index. Te duration of CPR was defned as the time interval from the frst chest compression provided by healthcare providers to the termination of resuscitation eforts due to ROSC (more than 20 min),ROSB after CPR, or a declaration of death. A favorable neurologic outcome was defned as a CPC score of 1 or 2 on the fve-category scale.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with cardiac arrest
Key inclusion criteria (4 listed)
- age more than 18 years,
- sudden arrest with potentially reversible causes,
- a short no fow time (time interval from presumed arrest to CPR initiation)
- even for unwitnessed arrests
Key exclusion criteria (3 listed)
- presence of a terminal illness or malignancy, severe irreversible neurologic defcit,
- suspected or confrmed traumatic origin of arrest,
- no informed consent from the family
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 |
|---|---|---|
| Cardiopulmonary resuscitationCardiopulmonary resuscitation (CPR) is an emergency treatment for patients with respiratory arrest and cardiac arrest in an attempt to restore the patient to spontaneous breathing and heartbeat through cardiopulmonary resuscitation | Procedure or surgery | – |
Primary outcome
indicators of survival
Time frame: an average of 1 year
The survival outcome was analyzed with logstic regression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiopulmonary Resuscitation
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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.
Genglong Liu study chair
Southern Medical University, China
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 Resuscitation, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 3 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 24 Jul 2018. 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 China. 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 Genglong Liu, MD (+8615626405844, lglong3@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
indicators of survival (time frame: an average of 1 year). 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 24 Jul 2018.