Cardiopulmonary Arrest OutcomeNCT00998140
Optimizing Resuscitation After Cardiac Arrest in the Community
An observational study of Cardiopulmonary Arrest Outcome, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Resuscitative efforts have been shown to be unsuccessful in most cases of out-of-hospital cardiac arrest (OHCA), and survivors who do recover cardiac function often sustain severe hypoxic brain damage. Time to efficacious care is a primary determinant of disability-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest Outcome
- How many people
- 1,600 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2009to Oct 2021
- 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: All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.
Who may be able to join
- All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.
Who cannot join
- Patients with do-not-resuscitate orders or an advance directive to that effect.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Resuscitation After Cardiac Arrest in the Community: Increasing the Probability of Survival While Reducing Costs
Resuscitative efforts have been shown to be unsuccessful in most cases of out-of-hospital cardiac arrest (OHCA), and survivors who do recover cardiac function often sustain severe hypoxic brain damage. Time to efficacious care is a primary determinant of disability-free survival. In the Jerusalem district, only 9% of OHCA patients present with ventricular tachycardia/ventricular fibrillation (VT/VF) as the primary rhythm, whereas 77% present with asystole; this seems primarily to be the result of long collapse-to-arrival times. Nevertheless, overly zealous resuscitation is undertaken in a high proportion of arrests with a futile prognosis, leading to excessive costs.
Study hypotheses:
- Subpopulations for whom intervention is futile/counter-productive are identifiable
- Substantial waste of resources can be avoided
- Optimization of emergency medical services (EMS) reorganization without adding resources is an achievable goal
- Conditions
- Cardiopulmonary Arrest Outcome
- Keywords
- resuscitation, sudden death, cardiopulmonary resuscitation, emergency medical services, termination of resuscitation, ventricular fibrillation, out-of-hospital cardiac arrest, asystole, medical futility, withdrawing treatment, transportation of patients, health expenditures, healthcare costs
- Medical subject headings
- Death, Sudden, Ventricular Fibrillation, Out-of-Hospital Cardiac Arrest, Heart Arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary Arrest OutcomeStudies 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
- Other
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sharon Einav, Shaare Zedek Medical Center
- Investigators
- Sharon Einav, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998140
- Sponsor's protocol ID
- NIHPR 08/90/a
- Status last verified
- Nov 2020
- First submitted
- 18 Oct 2009
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Pachys G, Kaufman N, Bdolah-Abram T, Kark JD, Einav S. Predictors of long-term survival after out-of-hospital cardiac arrest: the impact of Activities of Daily Living and Cerebral Performance Category scores. Resuscitation. 2014 Aug;85(8):1052-8. doi: 10.1016/j.resuscitation.2014.03.312. Epub 2014 Apr 12.
PubMed 24727137
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Resuscitation After Cardiac Arrest in the Community: Increasing the Probability of Survival While Reducing Costs
- ClinicalTrials.gov ID
- NCT00998140
- Acronym / sponsor ID
- NIHPR 08/90/a
- Conditions
- Cardiopulmonary Arrest Outcome
- Keywords
- resuscitation, sudden death, cardiopulmonary resuscitation, emergency medical services, termination of resuscitation, ventricular fibrillation, out-of-hospital cardiac arrest, asystole
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 20 Oct 2009 (estimated)
- 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.
Resuscitative efforts have been shown to be unsuccessful in most cases of out-of-hospital cardiac arrest (OHCA), and survivors who do recover cardiac function often sustain severe hypoxic brain damage. Time to efficacious care is a primary determinant of disability-free survival. In the Jerusalem district, only 9% of OHCA patients present with ventricular tachycardia/ventricular fibrillation (VT/VF) as the primary rhythm, whereas 77% present with asystole; this seems primarily to be the result of long collapse-to-arrival times. Nevertheless, overly zealous resuscitation is undertaken in a high proportion of arrests with a futile prognosis, leading to excessive costs.
Study hypotheses:
- Subpopulations for whom intervention is futile/counter-productive are identifiable
- Substantial waste of resources can be avoided
- Optimization of emergency medical services (EMS) reorganization without adding resources is an achievable goal
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.
Key inclusion criteria (1 listed)
- All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.
Key exclusion criteria (1 listed)
- Patients with do-not-resuscitate orders or an advance directive to that effect.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Results publication: PubMed 24727137Pachys G, Kaufman N, Bdolah-Abram T, Kark JD, Einav S. Predictors of long-term survival after out-of-hospital cardiac arrest: the impact of Activities of Daily Living and Cerebral Performance Category scores. Resuscitation. 2014 Aug;85(8):1052-8. doi: 10.1016/j.resuscitation.2014.03.312. Epub 2014 Apr 12.
- Individual participant dataSharing planned: Yes
Related trials for Cardiopulmonary Arrest Outcome
RecruitingObservational study
Predictive Outcome in Comatose Patients
Coma, Heart Arrest
Not yet recruitingObservational study
Timing for Computed Tomography and Post-Resuscitation Care on Short-Term Outcomes in Out-of-Hospital Cardiac Arrest
Out of Hospital Cardiac Arrest, Computed Tomography
RecruitingObservational study
Validity of ICU Clinician's Appraisal of Proportionality in CPR
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
Efficacy and Safety of TTM in Adults With ECPR.
Cardiac Arrest
RecruitingObservational study
Cardiopulmonary Resuscitation in Operating Room
Intraoperative Cardiac Arrest
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.
Sharon Einav, MD principal investigator
Shaare Zedek Medical Center
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 Outcome, run by Shaare Zedek Medical Center at 1 site in Israel.
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 16 Nov 2020. 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 Israel. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00998140, which also lists 1 linked publication.
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 Nov 2020.