Mild therapeutic hypothermia
ProcedureMild therapeutic hypothermia with a target temperature between 32-34°C.
NCT Number: NCT02066753
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Department of Anesthesiology and Intensive Care Medicine, Aarhus University Hospital, Skejby, Aarhus N, Central Jutland, Denmark
The PhD-study contains 3 sub studies:
-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.
-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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Mild therapeutic hypothermia with a target temperature between 32-34°C.
Time frame: In the intervention period from 24 to 72 hours
Allocated sub study 1
Time frame: After 24 hours, 48 hours and 72 hours
Allocated sub study 2
Time frame: From target temperature (32-34°C) has been reached until 72 hours after
Allocated sub study 3
Time frame: From target temperature (32-34°C) has been reached until 72 hours after
Allocated sub study 3
Time frame: In the intervention period from 24 to 72 hours
Allocated sub study 1
University of Aarhus
Other
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