CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 950 target
Drug / intervention
Target temperature 36°C +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01020916
NCT01020916N/ACompleted

Target Temperature Management 33°C Versus 36°C After Out-of-hospital Cardiac Arrest, a Randomised, Parallel Groups, Assessor Blinded Clinical Trial

Niklas Nielsen·interventional·Posted Nov 26, 2009·Updated Jul 10, 2013

In Brief

A clinical study evaluating Target temperature 36°C and Target Temperature 33°C for Out-of-hospital Cardiac Arrest. Completed, enrolled 950 participants across 33 sites in 10 countries.

Detailed Summary

Experimental studies and previous clinical trials suggest an improvement in mortality and neurological function with hypothermia after cardiac arrest. However, the accrued evidence is inconclusive and associated with risks of systematic error, design error and random error. Elevated body temperature after cardiac arrest is associated with a worse outcome. Previous trials did not treat elevated body temperature in the control groups. The optimal target temperature for post-resuscitation care is not known. The primary purpose with the TTM-trial is to evaluate if there are differences in all-cause mortality, neurological function and adverse events between a target temperature management at 33°C and 36°C for 24 hours following return of spontaneous circulation after cardiac arrest.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Czechia, Denmark, Italy, Luxembourg, Netherlands, Norway, Sweden, Switzerland, United Kingdom

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 26, 2009
Enrollment StartNov 1, 2010
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.6 years ago

Interventions

Target temperature 36°Cprocedure

In hospital target temperature management to achieve a core body temperature of 36°C for 24 hours

Target Temperature 33°Cprocedure

In hospital target temperature management to achieve a core body temperature of 33°C for 24 hours