Comparison on the Efficacy of a Monophasic | NCT00472498

Studies
Comparison on the Efficacy of a Monophasic

NCT00472498

Sponsor

Emory University

Status

Terminated

Last Update Posted

Sep 27, 2013Estimated

Enrollment

95Actual

Phase

Not provided

Conditions

Cardiac Arrest

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Terminated: No longer recruiting.

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Apr 16, 2007

First Submission Date that Met QC Criteria

May 10, 2007

First Posted Date

May 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2013

Last Update Posted Date

Sep 27, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Samuel C. Dudley, Jr., Principal Investigator, Emory UniversityPrincipal Investigator

Lead Sponsor

Emory UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Case: Patients resuscitated after 2001
2		Control: Patients who suffer cardiac arrests after 2001.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
s who suffered a cardiac arrest while hospitalized at the VA and were resuscitated		Information on patients who suffered cardiac arrest before 2001

Secondary Outcomes

Measure	Description	Time Frame
This study is observational.		Comparison before and after 2001

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Biphasic defibrillators were implemented Cardiac arrest before 2001

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who are hospitalized at the Atlanta VAMC hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samuel C Dudley, MD, PhD	US Department of Veterans Affairs	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15312869	Result	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.
17452161	Result	Bloom 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.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases