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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00676598
First Posted: May 13, 2008
Last Update Posted: January 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christine Kulstad, Advocate Hospital System
  Purpose

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.


Condition
Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by Christine Kulstad, Advocate Hospital System:

Enrollment: 70
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676598


Locations
United States, Illinois
Adcovate Christ Hospital
Oak Lawn, Illinois, United States, 60453
Sponsors and Collaborators
Advocate Hospital System
Investigators
Study Chair: Erik B Kulstad, MD,MS Advocate Christ Medical center
  More Information

Responsible Party: Christine Kulstad, Attending Physician, Advocate Hospital System
ClinicalTrials.gov Identifier: NCT00676598     History of Changes
Other Study ID Numbers: AHCIRB 4305
First Submitted: May 12, 2008
First Posted: May 13, 2008
Last Update Posted: January 6, 2012
Last Verified: January 2012

Keywords provided by Christine Kulstad, Advocate Hospital System:
therapeutic hypothermia

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms