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

NCT ID: NCT00676598

Last Updated: 2012-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Arrest

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advocate Hospital System

OTHER

Sponsor Role lead

Responsible Party

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Christine Kulstad

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik B Kulstad, MD,MS

Role: STUDY_CHAIR

advocate christ medical center

Locations

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Adcovate Christ Hospital

Oak Lawn, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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AHCIRB 4305

Identifier Type: -

Identifier Source: org_study_id

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