CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 329 enrolled
Drug / intervention
Therapeutic Hypothermia +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.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00880087
NCT00880087N/ACompleted

Therapeutic Hypothermia After Pediatric Cardiac Arrest (In Hospital)

University of Michigan·interventional·Posted Apr 13, 2009·Updated Jun 15, 2018

In Brief

A clinical study evaluating Therapeutic Hypothermia and Therapeutic Normothermia for Cardiac Arrest. Completed, enrolled 329 participants across 33 sites in 3 countries.

Detailed Summary

Cardiac arrest is a sudden, unexpected loss of heart function. Therapeutic hypothermia, in which the body's temperature is lowered and maintained several degrees below normal for a period of time, has been used to successfully treat adults who have experienced cardiac arrest. This study will evaluate the efficacy of therapeutic hypothermia at increasing survival rates and reducing the risk of brain injury in infants and children who experience a cardiac arrest while in the hospital.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Arrest
CountriesCanada, United Kingdom, United States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2009
Enrollment StartSep 1, 2009
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 17.2 years ago

Interventions

Therapeutic Hypothermiaprocedure

Participants who are assigned to receive therapeutic hypothermia will be cooled to a target temperature of 33º C plus or minus 1º C (32° to 34º C). This temperature will be maintained for 48 hours (2 days) and then participants will be warmed to a target temperature of 36.75º C plus or minus 0.75º C (36° to 37.5º C). This temperature will be maintained until 120 hours (5 days) after the cardiac arrest.

Therapeutic Normothermiaprocedure

Participants who are assigned to receive therapeutic normothermia will have their temperature maintained at 36.75º C plus or minus 0.75º C (36° to 37.5º C) for 120 hours (5 days) after the cardiac arrest.