Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial (THAPCA-IH)
|ClinicalTrials.gov Identifier: NCT00880087|
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : June 15, 2018
Last Update Posted : June 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Procedure: Therapeutic Hypothermia Procedure: Therapeutic Normothermia||Not Applicable|
Cardiac arrest occurs when the heart suddenly stops beating and blood flow to the body is halted. It can occur while people are in the hospital because of a medical condition or while people are out of the hospital as a result of an accident or other cause. Cardiac arrest is a serious event that is associated with high rates of death and long-term disability. When a person experiences cardiac arrest,insufficient amount of blood flow and oxygen can result in brain injury.
Therapeutic hypothermia is a therapy that involves a controlled lowering of the body temperature and then maintenance of this lower temperature for a period of time. Therapeutic hypothermia has been successfully used in adults who experience cardiac arrest to improve survival rates and health outcomes, and it has also been studied in newborn infants who have suffered from perinatal asphyxia. The purpose of this study is to evaluate the efficacy of therapeutic hypothermia at improving survival rates and reducing brain injury in infants and children who experience cardiac arrest while in the hospital.
Study researchers will conduct this study in collaboration with the following two pediatric clinical research networks: the Pediatric Emergency Care Applied Research Network (PECARN), funded by the Emergency Medical Services for Children (EMSC) program, and the National Institute of Child Health and Human Development (NICHD) Collaborative Pediatric Critical Care Research Network (CPCCRN).
The study will enroll infants and children who have suffered a cardiac arrest while in the hospital. Randomization must occur within 6 hours of return of spontaneous circulation. Participants will be randomly assigned to receive either therapeutic hypothermia or therapeutic normothermia. Participants receiving therapeutic hypothermia will have their body temperature reduced to between 32° and 34° Celsius (C) and will remain at this temperature for 2 days. Their body temperature will then be slowly increased to the normal temperature of 36° to 37.5° C, which will be maintained until 5 days after the cardiac arrest. Participants receiving therapeutic normothermia will have their normal temperature maintained between 36° and 37.5° C for 5 days after the cardiac arrest. Special temperature control blankets will be placed to maintain their body temperature in the assigned range. After 5 days, each participant's temperature will be managed by their medical care team.
While participants are in the hospital, they will undergo frequent blood and urine collections, chest x-rays, and temperature measurements; parents of participants will complete questionnaires. When participants are ready to leave the hospital, study researchers will perform a physical and functional assessment. Twenty-eight days after the cardiac arrest, researchers will contact parents of participants to gather information on the participants' health and medical condition. At Months 3 and 12, a child development expert will contact parents to gather medical information. At Month 12, participants will attend a study visit for a neurologic examination and testing with a psychologist trained in rehabilitation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||329 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Therapeutic Hypothermia After Pediatric Cardiac Arrest (In Hospital)|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Therapeutic Hypothermia
Participants will receive therapeutic hypothermia after experiencing cardiac arrest.
Procedure: Therapeutic Hypothermia
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.
Active Comparator: Therapeutic Normothermia
Participants will receive therapeutic normothermia after experiencing cardiac arrest.
Procedure: Therapeutic Normothermia
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.
- Survival With Good Neurobehavioral Outcome [ Time Frame: Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date. ]Survival at one-year anniversary of cardiac arrest, with a standardized VABS-II score of 70 or greater per evaluation performed at any time from 30 days prior to until 183 days after the one-year anniversary of cardiac arrest. Higher values of VABS-II represent a better outcome.
- Survival [ Time Frame: Measured at one-year anniversary of cardiac arrest. ]Survival at one year after cardiac arrest
- Change in Neurobehavioral Function From Pre-cardiac Arrest to 12 Months Post-cardiac Arrest [ Time Frame: Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date. ]Change in VABS-II score from baseline to one year, with death at 1 year treated as worst possible outcome, and lowest possible VABS-II score at one year (regardless of baseline VABS-II score) treated as the second worst possible outcome. Since higher levels of VABS-II represent a better outcome, a larger decline (large negative magnitude of change) in VABS-II score from baseline to one year represents a worse outcome.
- Neuropsychological Scores (for Participants Who Survive) [ Time Frame: Measured at Month 12 ]Functioning, as assessed by the Mullen Early Learning Composite (for children age < 5 years 9 months) or by the 2-subset version of the Wechsler Abbreviated Scale of Intelligence (WASI). As these two function measures are scaled in the same fashion, the two age groups are combined.
- Neurological Abnormality Scores (for Participants Who Survive) [ Time Frame: Measured at Month 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880087
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|Principal Investigator:||Frank Moler, MD||University of Michigan|
|Principal Investigator:||Michael Dean, MD||University of Utah|