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Hypothermia After in-Hospital Cardiac Arrest (HACAinhospital)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Schleswig-Holstein.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00457431
First received: April 4, 2007
Last updated: June 5, 2008
Last verified: June 2008

April 4, 2007
June 5, 2008
April 2007
April 2010   (final data collection date for primary outcome measure)
all cause mortality at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
all cause mortality at 6 months
Complete list of historical versions of study NCT00457431 on ClinicalTrials.gov Archive Site
  • 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 ]
  • neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale
  • in-hospital all cause mortality
Not Provided
Not Provided
 
Hypothermia After in-Hospital Cardiac Arrest
Hypothermia After in-Hospital Cardiac Arrest

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Cardiac Arrest
Procedure: Mild therapeutic hypothermia
Mild therapeutic hypothermia will be performed by any methods applicable in the hospitals
  • No Intervention: 1
    Standard therapy as used in the hospital's ICU
    Intervention: Procedure: Mild therapeutic hypothermia
  • Active Comparator: 2
    Standard therapy as used in the hospital's ICU plus Hypothermia
    Intervention: Procedure: Mild therapeutic hypothermia
Soar J, Nolan JP. Mild hypothermia for post cardiac arrest syndrome. BMJ. 2007 Sep 8;335(7618):459-60. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
440
Not Provided
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sebastian Wolfrum, MD +49451500 ext 2501 wolfrum@medinf.mu-luebeck.de
Contact: Volkhard Kurowski, MD +49451500 ext 2330
Germany
 
NCT00457431
HACA in-hospital
Yes
Dr. Sebastian Wolfrum, Medical University of Luebeck, Germany
University of Schleswig-Holstein
Not Provided
Principal Investigator: Sebastian Wolfrum, MD University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II
University of Schleswig-Holstein
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP