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Time-differentiated Therapeutic Hypothermia (TTH48)

This study is not yet open for participant recruitment.
Verified September 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01689077
First received: September 17, 2012
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of this study is to determine if 48 hours of mild therapeutic hypothermia following out of hospital cardiac arrest gives a better cerebral outcome compared to 24 hours therapeutic hypothermia.


Condition Intervention
Out of Hospital Cardiac Arrest
 Procedure: Therapeutic hypothermia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Time-differentiated Treatment With Mild Therapeutic Hypothermia Following Cardiac Arrest, a Multi Center Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • CPC [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    CPC = Cerebral Performance Category Score


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    Adverse events are registered during the treatment and the following 7 days


Other Outcome Measures:
  • MMSE and ACE [ Time Frame: Day 4 and 6 month ] [ Designated as safety issue: No ]
    Minimal Mental State Examination (MMSE) and Addenbrook's Cognitive Examination (ACE) are measured day four 4 and after 6 month


Estimated Enrollment: 340
Study Start Date: October 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 24 hours hypothermia
24 hours hypothermia
 Procedure: Therapeutic hypothermia
Mild therapeutic hypothermia with a target temperature of 33 degrees centigrade
Experimental: 48 hours hypothermoa
48 hours hypothermia
 Procedure: Therapeutic hypothermia
Mild therapeutic hypothermia with a target temperature of 33 degrees centigrade

Detailed Description:

Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death. However, in 2002 it was in two clinical trials demonstrated that mild therapeutic hypothermia in comatose OOH-CA victims yields a better cerebral outcome measured by Cerebral Performance Category Score (CPC) after 6 month. The optimal mild hypothermia treatment time is however not known. The two trials from 2002 apply the treatment for 12 and 24 hours respectively. In newborns with cerebral hypoxic damage the standard treatment time is 72 hours. It is therefore relevant to investigate the influence of the treatment time on the cerebral outcome in OOH-CA victims. In the present study cerebral outcome after mild therapeutic hypothermia (target temperature 33 degrees centigrade) in OOH_CA patients for 24 is compared to outcome after 48 hours of mild hypothermia. The main outcome parameter is mortality and CPC score measured 6 month after the treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Out of hospital cardiac arrest of suspected cardiac origion
  2. Return of spontaneous circulation (ROSC)
  3. Glasgow Coma Score < 8
  4. Estimated time interval from cardiac arrest to ROSC ≤ 60 min

Exclusion Criteria:

  1. OUH-CA of suspected origin other than cardiac
  2. In hospital Cardiac arrest
  3. Terminal disease
  4. Coagulation disorders
  5. Unwitnessed asystolia
  6. Time from cardiac arrest to start of hypothermia treatment > 240 min
  7. GCS ≥ 8
  8. Pregnancy
  9. Persistent cardiogenic shock (Systolic blood pressure < 80 mmHg despite inotropic treatment and aortic balloon pump).
  10. CPC 3-4 before cardiac arrest
  11. Acute intra cerebral bleeding
  12. Acute stroke
  13. Acute CABG
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01689077

Contacts
Contact: Hans Kirkegaard, Professor 004528149787 hanskirkegaard@dadlnet.dk

Locations
Denmark
Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Aalborg Not yet recruiting
Aalborg, Denmark, 9000
Contact: Inge De Haas, MD     004599328588     dehaas@dadlnet.dk    
Principal Investigator: Inge De Haas, MD            
Department og Anesthesiologi and Intensive Care Medicine, Not yet recruiting
Aarhus, Denmark, 8200
Contact: Hans Kirkegaard, Professor     004528149783     hanskirkegaard@dadlnet.dk    
Contact: Susanne Ilkjaer, MD, PhD            
Principal Investigator: Susanne Ilkjaer, MD, PhD            
Department of Anaesthesiology and Intensive Care Medicine, Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Henrik Schmidt, MD, DrMedSci     004565412411     henrik.schmidt@ouh.regionsyddammark.dk    
Principal Investigator: Henrik Schmidt, MD, DrMedSci            
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Hans Kirkegaard, Professor Department of Anaesthesia and Intensive care medicine, Aarhus University Hosptal, Brendstrupgaardsvej 8200 Aarhus, Denmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01689077     History of Changes
Other Study ID Numbers: TTH48
Study First Received: September 17, 2012
Last Updated: September 24, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Out-of-Hospital Cardiac Arrest
Heart Diseases
 Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013