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Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients (The THAPCA-IH [In Hospital] Study)
This study is not yet open for participant recruitment.
Verified by National Heart, Lung, and Blood Institute (NHLBI), April 2009
First Received: April 10, 2009   Last Updated: April 27, 2009   History of Changes
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00880087
  Purpose

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 effectiveness 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.


Condition Intervention Phase
Heart Arrest
Procedure: Hypothermia
Procedure: Normothermia
Phase II

MedlinePlus related topics: Hypothermia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Therapeutic Hypothermia After Pediatric Cardiac Arrest (In Hospital)

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Survival with good neurobehavioral outcome [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: Yes ]
  • Change in neurobehavioral function from pre-cardiac arrest to 12 months post-cardiac arrest [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Neuropsychological scores (for participants who survive) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Neurological abnormality scores (for participants who survive) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive therapeutic hypothermia after experiencing cardiac arrest.
Procedure: Hypothermia
Participants who are assigned to receive 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.
2: Active Comparator
Participants will receive therapeutic normothermia after experiencing cardiac arrest.
Procedure: Normothermia
Participants who are assigned to receive 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.

Detailed Description:

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 injury. Cardiac arrest is a serious event that is associated with high rates of death and long-term disability. When a person experiences cardiac arrest, the body undergoes severe stress and releases toxic compounds that can overwhelm the body's organs. For instance, these compounds can cause long-term brain injury.

Therapeutic hypothermia is a treatment method that involves a controlled lowering of the body temperature and then maintenance of this lower temperature for a period of time. The treatment may sufficiently slow the body's production of toxic compounds to prevent brain injury. 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, which is a loss of oxygen. The purpose of this study is to evaluate the effectiveness 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 in the 6 hours before study entry while in the hospital. Participants will be randomly assigned to receive either hypothermia or normothermia. Participants receiving 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 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 on participants 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suffered a cardiac arrest requiring chest compressions for at least 2 minutes, with the return of spontaneous circulation (ROSC)/return of circulation (ROC)
  • More than 48 hours of age (with a corrected gestational age of at least 38 weeks) and less than 18 years of age
  • Requires continuous mechanical ventilation
  • Cardiac arrest is unplanned (i.e., not part of a cardiac surgical procedure)
  • Parent or legal guardian speaks English or Spanish

Exclusion Criteria:

  • Had an additional cardiac arrest requiring chest compressions for at least 2 minutes after initial ROSC/ROC of 20 minutes or longer but before being randomly assigned to a study treatment
  • Study entry is impossible within 6 hours of ROSC/ROC
  • On extracorporeal membrane oxygenation (ECMO) when the cardiac arrest occurred
  • Received continuous infusion of epinephrine or norepinephrine at very high doses (greater than or equal to 2 μg/kg/minute) immediately before being randomly assigned to a study treatment
  • A Glascow Coma Scale motor response of 5 (i.e., localizing pain or for infants less than 2 years old, withdraws to touch) or 6 (i.e., obeys commands, or for infants, normal spontaneous movement) before study entry
  • History of a prior cardiac arrest with chest compressions for at least 2 minutes during the current hospitalization
  • Pre-existing terminal illness with life expectancy of less than 12 months
  • Lack of commitment to aggressive intensive care therapies, including do not resuscitate orders or other limitations to care
  • Cardiac arrest associated with severe brain, thoracic, or abdominal trauma
  • Active and refractory severe bleeding before being randomly assigned to a study treatment
  • Experienced near drowning in ice water with a core temperature of less than or equal to 32° C on presentation
  • Pregnant
  • Currently enrolled in another interventional study
  • Newborn (less than 48 hours of age) with a history of acute birth asphyxia
  • Cared for in a neonatal intensive care unit (NICU) after cardiac arrest (i.e., would not be admitted to pediatric intensive care unit [PICU])
  • Sickle cell anemia
  • Pre-existing cryoglobulinemia
  • Has a central nervous system tumor and receiving ongoing chemotherapy or radiation therapy
  • Progressive degenerative encephalopathy
  • Any condition in which direct skin surface cooling would be medically unadvisable, such as large burns, decubitus ulcers, cellulitis, or other conditions with disrupted skin integrity (NOTE: people with open chest cardiopulmonary resuscitation [CPR] can be enrolled but placement of cooling mattresses will be modified as needed)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880087

Contacts
Contact: J. Michael Dean, MD, MBA 801-587-7572 mike.dean@hsc.utah.edu
Contact: Brittan Browning, MS, RD, CCRC 801-587-7568 brittan.browning@hsc.utah.edu

Sponsors and Collaborators
Investigators
Principal Investigator: Frank Moler, MD University of Michigan
Principal Investigator: Kathy Meert, MD Children's Hospital of Michigan
  More Information

No publications provided

Responsible Party: University of Utah School of Medicine ( J. Michael Dean, MD, MBA, Professor of Pediatrics )
Study ID Numbers: 620, U01 HL094345
Study First Received: April 10, 2009
Last Updated: April 27, 2009
ClinicalTrials.gov Identifier: NCT00880087     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Cardiac Arrest
Cardiopulmonary Arrest
Pediatric Cardiac Arrest

Study placed in the following topic categories:
Signs and Symptoms
Hypothermia
Heart Diseases
Heart Arrest

Additional relevant MeSH terms:
Signs and Symptoms
Hypothermia
Heart Diseases
Cardiovascular Diseases
Heart Arrest
Body Temperature Changes

ClinicalTrials.gov processed this record on May 07, 2009