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Hypothermia After In-hospital Cardiac Arrest (HACAinhospital)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by University of Schleswig-Holstein
Sponsor:
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • all cause mortality at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • in-hospital all cause mortality [ Time Frame: time until discharge or death ] [ Designated as safety issue: Yes ]
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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Health Authority: Germany: Ethics Commission

Keywords provided by 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 September 29, 2016