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Hypothermia After In-hospital Cardiac Arrest (HACAinhospital)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Sebastian Wolfrum, University of Schleswig-Holstein.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
University of Schleswig-Holstein
Collaborators:
University of Hamburg
University of Leipzig
University of Jena
Information provided by (Responsible Party):
Sebastian Wolfrum, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00457431
First received: April 4, 2007
Last updated: June 12, 2015
Last verified: June 2015
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Purpose
ILCOR Recommendations "On the basis of the published evidence to date, the Advanced Life Support (ALS) Task Force of the International Liaison Committee on Resuscitation (ILCOR) made the following recommendations in October 2002: Unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32°C to 34°C for 12 to 24 hours when the initial rhythm was ventricular fibrillation (VF).Such cooling may also be beneficial for other rhythms or in-hospital cardiac arrest" (Circulation. 2003;108:118-121). This study ist to investigate the efficacy of mild therapeutic hypothermia on mortality and neurological outcome in patients after in-hospital cardiac arrest.
| Condition | Intervention |
|---|---|
| Cardiac Arrest | Procedure: Mild therapeutic hypothermia |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Hypothermia After In-hospital Cardiac Arrest |
Resource links provided by NLM:
Further study details as provided by Sebastian Wolfrum, University of Schleswig-Holstein:
Primary Outcome Measures:
- all cause mortality at 6 months [ Time Frame: 6 months ]
Secondary Outcome Measures:
- neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale [ Time Frame: 6 months ]
- in-hospital all cause mortality [ Time Frame: time until discharge or death ]
| Estimated Enrollment: | 440 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Control
Standard therapy as used in the hospital's ICU
|
|
|
Active Comparator: Hypothermia
Standard therapy as used in the hospital's ICU plus Hypothermia
|
Procedure: Mild therapeutic hypothermia
Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals
|
Detailed Description:
This is a randomized controlled multicenter trial. Patients after in-hospital cardiac arrest are randomized either to standard therapy or to standard therapy in addition to mild therapeutic hypothermia. Mild therapeutic hypothermia is performed for 24 hours with a target temperature of 32-34°C. Inclusion criteria are: Adult patients which have been resuscitated after cardiac arrest in-hospital and who remain unconscious after restoration of spontanous circulation. Exclusion criteria are: severe cardiogenic shock, severe rhythm disorders, major surgery within the last 10 days, planned surgery within the next 24 hours afer resuscitation, active bleeding, suspicion od intracranial bleeding, severe infection, such as pneumonia or sepsis, a severe neurological deficit before cardiac arrest, an aquired immun deficency, pregnacy. The primary endpoint is mortality for all causes after six months. Secondary endpoints are neurological outcome after six months measured by the Glasgow-Pittsburgh Cerebral Performance scale, and in-hospital-mortality.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- in-hospital cardiac arrest
- restoration of spontanous circulation
- unconsciousness
- age over 18
- initiation of mild therapeutic hypothermia is possible within 4h after resuscitation
Exclusion Criteria:
- active bleeding
- suspicion of intra cranial bleeding
- severe infection
- aquired immun deficency
- severe rhythm disorders
- suspicion of cerebral insult
- known severe cognotive deficit before the index event
- pregnancy
- pre existing disease which makes 6 months survival unlikely
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00457431
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457431
Contacts
| Contact: Sebastian Wolfrum, MD | +49451500 ext 2501 | wolfrum@medinf.mu-luebeck.de | |
| Contact: Volkhard Kurowski, MD | +49451500 ext 2330 |
Locations
| Germany | |
| University of Schleswig-Holstein, Campus Lübeck, Medical Clinic II | Recruiting |
| Lübeck, Germany, 23538 | |
| Contact: Sebastian Wolfrum, MD +49451500 ext 2501 swolfrum@online.de | |
| Principal Investigator: Sebastian Wolfrum, MD | |
Sponsors and Collaborators
University of Schleswig-Holstein
University of Hamburg
University of Leipzig
University of Jena
Investigators
| Principal Investigator: | Sebastian Wolfrum, MD | University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sebastian Wolfrum, D. Sebastian Wolfrum, University of Schleswig-Holstein |
| ClinicalTrials.gov Identifier: | NCT00457431 History of Changes |
| Other Study ID Numbers: |
HACA in-hospital |
| Study First Received: | April 4, 2007 |
| Last Updated: | June 12, 2015 |
Keywords provided by Sebastian Wolfrum, University of Schleswig-Holstein:
|
in-hospital cardiac arrest resuscitation mild 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 July 26, 2017