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Hypothermia After In-hospital Cardiac Arrest (HACAinhospital)

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.
 
ClinicalTrials.gov Identifier: NCT00457431
Recruitment Status : Terminated (interim analysis with stopping for futility)
First Posted : April 6, 2007
Last Update Posted : June 22, 2021
Sponsor:
Collaborators:
University of Hamburg-Eppendorf
University of Leipzig
University of Jena
Information provided by (Responsible Party):
Sebastian Wolfrum, University Hospital Schleswig-Holstein

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Arrest Procedure: Mild therapeutic hypothermia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hypothermia After In-hospital Cardiac Arrest
Actual Study Start Date : April 3, 2007
Actual Primary Completion Date : November 9, 2014
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. all cause mortality at 6 months [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. neurological outcome at six months measured by the Glasgow-Pittsburgh cerebral performance scale [ Time Frame: 6 months ]
  2. in-hospital all cause mortality [ Time Frame: time until discharge or death ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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): NCT00457431


Locations
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Germany
Sebastian Wolfrum
Lübeck, Schleswig-Holstein, Germany, 23538
Sponsors and Collaborators
University Hospital Schleswig-Holstein
University of Hamburg-Eppendorf
University of Leipzig
University of Jena
Investigators
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Principal Investigator: Sebastian Wolfrum, MD University of Schleswig-Holstein, Campus Luebeck, Medical Clinic II
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sebastian Wolfrum, D. Sebastian Wolfrum, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00457431    
Other Study ID Numbers: HACA in-hospital
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021
Keywords provided by Sebastian Wolfrum, University Hospital Schleswig-Holstein:
in-hospital cardiac arrest
resuscitation
mild therapeutic hypothermia
Additional relevant MeSH terms:
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Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes