Cardiac ArrestAEDNCT00472498
Comparison on the Efficacy of a Monophasic
An observational study of Cardiac Arrest, run by Emory University.
Trial summary
The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiac Arrest
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Feb 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are hospitalized at the Atlanta VAMC hospital.
Who may be able to join
- Clinical outcomes of patients who suffered a cardiac arrest while hospitalized and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.
Who cannot join
- Biphasic defibrillators were implemented Cardiac arrest before 2001
About this study
Official title: Comparison on the Efficacy of a Monophasic, Manually Operated Defibrillator to That of a Biphasic Automatic External Defibrillator in the Hospital Setting.
The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.
Read the detailed description
The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.
This study will retrospectively collect and analyze clinical data related to the Atlanta VA Medical Center, a member of the National Registry of Cardiopulmonary Resuscitation, to assess clinical parameters in cardiac arrest survivors.
This study focuses on collecting data retrospectively in regard to cardiac arrest patients to discern what factors are playing a role in patient survival after cardiac arrest. Such data will help hospitals and physicians to improve quality of care in patients at risk for cardiac arrest as well as to implement strategies to reduce such events or improve management of these high-risk patients in order to save lives.
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac Arrest, Biphasic Defibrillator
- 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 |
|---|---|---|
| 1 | Case: Patients resuscitated after 2001 | |
| 2 | Control: Patients who suffer cardiac arrests after 2001. |
What is being measured
The primary outcome is the main question the study is designed to answer.
s who suffered a cardiac arrest while hospitalized at the VA and were resuscitated
Measured: Information on patients who suffered cardiac arrest before 2001
Secondary outcomes (1)
This study is observational.
Measured: Comparison before and after 2001
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startJun 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Terminated: No longer recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Emory 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel C. Dudley, Jr., Emory University
- Investigators
- Samuel C Dudley, MD, PhD, Principal investigator, US Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472498
- Sponsor's protocol ID
- 206-2000
- Acronym
- AED
- Status last verified
- Sep 2013
- First submitted
- 16 Apr 2007
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Zafari AM, Zarter SK, Heggen V, Wilson P, Taylor RA, Reddy K, Backscheider AG, Dudley SC Jr. A program encouraging early defibrillation results in improved in-hospital resuscitation efficacy. J Am Coll Cardiol. 2004 Aug 18;44(4):846-52. doi: 10.1016/j.jacc.2004.04.054.
PubMed 15312869Bloom HL, Shukrullah I, Cuellar JR, Lloyd MS, Dudley SC Jr, Zafari AM. Long-term survival after successful inhospital cardiac arrest resuscitation. Am Heart J. 2007 May;153(5):831-6. doi: 10.1016/j.ahj.2007.02.011.
PubMed 17452161
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison on the Efficacy of a Monophasic, Manually Operated Defibrillator to That of a Biphasic Automatic External Defibrillator in the Hospital Setting.
- ClinicalTrials.gov ID
- NCT00472498
- Acronym / sponsor ID
- AED / 206-2000
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac Arrest, Biphasic Defibrillator
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated: No longer recruiting.
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 11 May 2007 (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.
The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.
Detailed description
The central purpose of this study is to compare the clinical outcomes of patients who suffered a cardiac arrest while hospitalized at the VA and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.
This study will retrospectively collect and analyze clinical data related to the Atlanta VA Medical Center, a member of the National Registry of Cardiopulmonary Resuscitation, to assess clinical parameters in cardiac arrest survivors.
This study focuses on collecting data retrospectively in regard to cardiac arrest patients to discern what factors are playing a role in patient survival after cardiac arrest. Such data will help hospitals and physicians to improve quality of care in patients at risk for cardiac arrest as well as to implement strategies to reduce such events or improve management of these high-risk patients in order to save lives.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Case: Patients resuscitated after 2001 |
| 2 | – | –Control: Patients who suffer cardiac arrests after 2001. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are hospitalized at the Atlanta VAMC hospital.
Key inclusion criteria (1 listed)
- Clinical outcomes of patients who suffered a cardiac arrest while hospitalized and were resuscitated after biphasic defibrillators were implemented in 2001 to clinical outcomes of patients who suffered cardiac arrest before 2001.
Key exclusion criteria (1 listed)
- Biphasic defibrillators were implemented Cardiac arrest before 2001
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
s who suffered a cardiac arrest while hospitalized at the VA and were resuscitated
Time frame: Information on patients who suffered cardiac arrest before 2001
1 secondary outcome
This study is observational.
Time frame: Comparison before and after 2001
Results and safety
The study was stopped early (reason given: Terminated: No longer recruiting.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
- Results publication: PubMed 15312869Zafari AM, Zarter SK, Heggen V, Wilson P, Taylor RA, Reddy K, Backscheider AG, Dudley SC Jr. A program encouraging early defibrillation results in improved in-hospital resuscitation efficacy. J Am Coll Cardiol. 2004 Aug 18;44(4):846-52. doi: 10.1016/j.jacc.2004.04.054.
- Results publication: PubMed 17452161Bloom HL, Shukrullah I, Cuellar JR, Lloyd MS, Dudley SC Jr, Zafari AM. Long-term survival after successful inhospital cardiac arrest resuscitation. Am Heart J. 2007 May;153(5):831-6. doi: 10.1016/j.ahj.2007.02.011.
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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.
Samuel C Dudley, MD, PhD principal investigator
US Department of Veterans Affairs
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Emory University.
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: stopped early, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Terminated: No longer recruiting.). 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.
What does the primary outcome measure?
s who suffered a cardiac arrest while hospitalized at the VA and were resuscitated (time frame: Information on patients who suffered cardiac arrest before 2001). 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 NCT00472498, which also lists 2 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 27 Sep 2013.