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NCT00676598 Clinical Trial

A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest

Cardiac Arrest Clinical Trial

Official title:
A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00676598
Other study ID # AHCIRB 4305
Secondary ID
Status Completed
Phase N/A
First received May 12, 2008
Last updated January 4, 2012
Start date January 2007
Est. completion date December 2010

Study information
Verified date January 2012
Source Advocate Hospital System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Therapeutic hypothermia has been shown to improve survival and neurologic outcome in patients resuscitated after ventricular fibrillation arrest.

Few studies have examined whether therapeutic hypothermia is effective outside the research setting, or with other presenting rhythms.

Our institution, a large community teaching hospital, instituted a therapeutic hypothermia protocol in November 2006 for all resuscitated cardiac arrest patients.

The investigators seek to determine the mortality rate of our protocol and compare our complication rates with those of previously published studies.

Description:

The use of therapeutic hypothermia has been shown to have a beneficial effect on neurologic outcomes of patients resuscitated from cardiac arrest in a limited number of clinical sites. Based on available data, current recommendations from the American Heart Association include a level 2a endorsement of therapeutic hypothermia for cardiac arrest from ventricular fibrillation with persistent coma, and a level 2b recommendation for cardiac arrest from any other rhythm. To date there have been no formal studies presented that demonstrate an improvement in outcome when a hypothermic protocol is implemented in a community hospital. The investigators plan to prospectively collect data on patients enrolled in the therapeutic hypothermia protocol to evaluate clinical outcomes and compare these outcomes with historic controls, with the hypothesis that patients enrolled in the hypothermic protocol will have improved neurologic outcomes.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date December 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.

Exclusion Criteria:

- hypotension (SBP <90), initial temperature < 30 °C, trauma, primary intracranial event, or active coagulopathy.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Adcovate Christ Hospital Oak Lawn Illinois

Sponsors (1)
Lead Sponsor Collaborator
Advocate Hospital System

Country where clinical trial is conducted

United States, 

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