NCT02066753

The Cardiac Effects of Prolonged Hypothermia After Cardiac Arrest

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Cardiac Arrest
• Hypothermia

Interventions

Type	Name	Description
PROCEDURE	Mild therapeutic hypothermia	Mild therapeutic hypothermia with a target temperature between 32-34°C.

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-02-19
• Last updated: 2015-11-25

Locations

2 sites across 2 countries: Denmark, Norway