A Prospective Analysis of the Effect of Therapeutic Hypothermia After Cardiac Arrest
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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 |
| 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) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Any adult non-pregnant patient who is unresponsive after resuscitation from cardiac arrest regardless of presenting rhythm and who survives to hospital admission.
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| United States, Illinois | |
| Adcovate Christ Hospital | |
| Oak Lawn, Illinois, United States, 60453 | |
| Study Chair: | Erik B Kulstad, MD,MS | Advocate Christ Medical center |
More Information
No publications provided
| Responsible Party: | Christine Kulstad, Attending Physician, Advocate Hospital System |
| ClinicalTrials.gov Identifier: | NCT00676598 History of Changes |
| Other Study ID Numbers: | AHCIRB 4305 |
| Study First Received: | May 12, 2008 |
| Last Updated: | January 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Advocate Hospital System:
|
therapeutic hypothermia |
Additional relevant MeSH terms:
|
Heart Arrest Hypothermia Heart Diseases |
Cardiovascular Diseases Body Temperature Changes Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013