The Cardiac Effects of Prolonged Hypothermia After Cardiac Arrest

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02066753
First received: February 17, 2014
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

This PhD study is a sub study in a randomized clinical controlled multicenter trial named "TTH48" (ClinicalTrials.gov Identifier: NCT01689077).

The TTH48 trial examines prolonged mild therapeutic hypothermia ("MTH") at 32-34°C in 24 versus 48 hours with the primary outcome Cerebral Performance Category after 6 month in comatose out-of-hospital cardiac arrest patients.

THE OVERALL AIM OF THIS PhD STUDY IS TO INVESTIGATE THE CARDIAC FUNCTION AND THE HEMODYNAMICS BY BIOCHEMICAL CARDIAC MARKERS, ECHOCARDIOGRAPHY, BY ANALYZING THE USAGE OF INOTROPES/VASOPRESSORS AND BY ANALYZING ECG DATA FOR ARRHYTHMIAS IN THE 24 VERSUS 48 HOURS MTH GROUPS.


Condition Intervention
Cardiac Arrest
Hypothermia
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: The Cardiac Effects of Prolonged Hypothermia After Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Area under the curve cTnT [ Time Frame: In the intervention period from 24 to 72 hours ] [ Designated as safety issue: No ]
    Allocated sub study 1

  • Mitral annular systolic velocity [ Time Frame: After 24 hours, 48 hours and 72 hours ] [ Designated as safety issue: No ]
    Allocated sub study 2

  • Duration of arrhythmias [ Time Frame: From target temperature (32-34°C) has been reached until 72 hours after ] [ Designated as safety issue: Yes ]
    Allocated sub study 3

  • Cumulative vasopressor index [ Time Frame: From target temperature (32-34°C) has been reached until 72 hours after ] [ Designated as safety issue: No ]
    Allocated sub study 3


Secondary Outcome Measures:
  • Area under the curve NT-proBNP [ Time Frame: In the intervention period from 24 to 72 hours ] [ Designated as safety issue: No ]
    Allocated sub study 1


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 24 hours mild therapeutic hypothermia
The patient will be treated with mild therapeutic hypothermia for 24 hours after reaching the target temperature between 32-34°C.
Procedure: Mild therapeutic hypothermia
Mild therapeutic hypothermia with a target temperature between 32-34°C.
Experimental: 48 hours mild therapeutic hypothermia
The patient will be treated with mild therapeutic hypothermia for 48 hours after reaching the target temperature between 32-34°C.
Procedure: Mild therapeutic hypothermia
Mild therapeutic hypothermia with a target temperature between 32-34°C.

Detailed Description:

The PhD-study contains 3 sub studies:

  • Study 1 estimates the extend of myocardial damage resulting from the primary arrest and from the reperfusion injuries: Area under the curve of cTnT and CK-MB as 12 repeated measurements and NT-proBNP as 4 measurements post arrest

    -Hypothesis: There is a statistically significantly greater release of the cardiac biomarkers cTnT and NT-proBNP quantified by the area under the curve in the 24 versus the 48 hours group in the intervention period from 24 to 72 hours.

  • Study 2 investigates MTH´s influence on systolic and diastolic function by standard and Tissue Doppler (TDI) echocardiography after 24, 48 and 72 hours. The primary endpoint is mitral annular systolic velocity ("S´ max")

    -Primary hypothesis: There is statistically significant improvement in S' max from the time T24 to T72 in the 48 versus the 24 hours group.

    -Secondary hypothesis: There is statistically significantly better systolic function at T48 measured in terms of individual S' max-change in the 48 hours group (still hypothermic) versus the 24 hours group (reached normothermia).

  • Study 3 investigates MTH´s influence on the need for vasopressor or inotrope and the duration of arrhythmias during the first 72 hours post arrest.

    • Primary hypothesis: There is a statistically significantly increased tendency of arrhythmias in the 48 versus the 24 hours group measured in the period from T0 to T72.
    • Secondary hypothesis: There is a statistically significantly reduced need for inotropes in the 48 versus the 24 hours group measured by cumulative vasopressor index in the period from T0 to T72.
  Eligibility

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

Inclusion Criteria:

  1. Resuscitated after cardiac arrest outside hospital with suspected cardiac triggering cause (and stabile circulation for at least 20 minutes after return of spontaneous circulation,
  2. Glasgow coma score < 8 and
  3. Age ≥ 18 years and < 80 years.

Exclusion Criteria:

  1. Cardiac arrest of suspected non-cardiac triggering cause (e.g. trauma, aortic dissection, massive bleeding, hypoxia or accidental hypothermia),
  2. >60 minutes from cardiac arrest to ROSC,
  3. Time from cardiac arrest until start of cooling >4 hours,
  4. Terminal illness,
  5. Coagulopathy (medical anticoagulation treatment including thrombolysis is not a contraindication),
  6. Unwitnessed arrests with asystolia as presenting rhythm,
  7. Pregnancy,
  8. Persistent cardiogenic shock,
  9. Systolic blood pressure <80 mmHg despite vasoactive treatment and intra-aortic balloon pump
  10. CPC 3-4 before the cardiac arrest,
  11. Suspected/confirmed acute intra cerebral hemorrhage or stroke,
  12. Acute CABG or other operation in connection with performing CPR,
  13. Lack of consent from the relatives,
  14. Lack of consent from the GP and
  15. Lack of consent from the patient if he/she wakes up and is relevant.
  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: NCT02066753

Contacts
Contact: Anders Grejs, MD +45 51948171 anders.grejs@dadlnet.dk

Locations
Denmark
Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Skejby Recruiting
Aarhus N, Central Denmark Region, Denmark, 8200
Contact: Anders Grejs, MD    +45 51948171    anders.grejs@dadlnet.dk   
Principal Investigator: Anders Grejs, MD         
Sub-Investigator: Hans Kirkegaard, Professor MD         
Sub-Investigator: Jakob Gjedsted, MD, PhD         
Sub-Investigator: Erik Sloth, Professor MD         
Sub-Investigator: Jens F Lassen, MD, PhD         
Norway
Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Stavanger University Hospital Not yet recruiting
Stavanger, Norway, 4068
Contact: Eldar Søreide, Professor MD       eldar.soreide@sus.no   
Principal Investigator: Eldar Søreide, Professor MD         
Sub-Investigator: Alf I Larsen, Professor MD         
Sub-Investigator: Per D Hamre, MD         
Sub-Investigator: Kristian Strand, MD         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Anders Grejs, MD Research Center of Emergency Medicine and Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Skejby, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02066753     History of Changes
Other Study ID Numbers: TTH48AG
Study First Received: February 17, 2014
Last Updated: February 19, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Cardiac arrest
Therapeutic Hypothermia
Cardioprotectiveness
Hemodynamics

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Body Temperature Changes
Cardiovascular Diseases
Heart Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014