Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frank W. Moler, M.D, M.S, University of Michigan
ClinicalTrials.gov Identifier:
NCT00878644
First received: April 8, 2009
Last updated: February 27, 2013
Last verified: February 2013
  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 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 out of the hospital.


Condition Intervention Phase
Cardiac Arrest
Procedure: Therapeutic Hypothermia
Other: Therapeutic Normothermia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Hypothermia After Pediatric Cardiac Arrest (Out of Hospital)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

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 that survive) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • Neurological abnormality scores (for participants that survive) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
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
Experimental: Therapeutic Hypothermia
Participants will receive therapeutic hypothermia after experiencing cardiac arrest.
Procedure: Therapeutic 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.
Other Name: Therapeutic hypothermia
Active Comparator: Therapeutic Normothermia
Participants will receive therapeutic normothermia after experiencing cardiac arrest.
Other: 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.
Other Name: Therapeutic normothermia

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 other causes. 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. The treatment may result in reduced 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. 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 out of 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 out of 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 to 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 to 37.5° C for 5 days after the cardiac arrest. Special temperature control blankets will be placed to maintain 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:

  • Patient suffered cardiac arrest requiring chest compressions for at least 2 minutes (120 seconds) with ROSC/ROC; AND
  • Age greater than 48 hours (with a corrected gestational age of at least 38 weeks) and less than 18 years; AND
  • Patient requires continuous mechanical ventilation; AND
  • The cardiac arrest was unplanned (i.e., not part of cardiac surgical procedure)

Exclusion Criteria:

  • The parent or legal guardian does not speak English or Spanish (the only two languages in which VABS II is standardized)
  • Randomization is impossible within six hours of ROSC; OR
  • Patient is on extracorporeal membrane oxygenation (ECMO) when arrest occurs; OR
  • Continuous infusion of epinephrine or norepinephrine at very high doses (≥2 ug/kg/minute) received immediately prior to randomization; OR Glasgow Coma Scale motor response of five (localizing pain or for infants less than two years, withdraws to touch) or six (obeys commands, or for infants, normal spontaneous movement) prior to randomization; OR
  • History of a prior cardiac arrest with chest compressions for at least two minutes during the current hospitalization but outside the 6 hour window for randomization; OR
  • Pre-existing terminal illness with life expectancy < 12 months; OR
  • Lack of commitment to aggressive intensive care therapies including do not resuscitate orders and other limitations to care; OR
  • Cardiac arrest was associated with severe brain, thoracic, or abdominal trauma; OR
  • Active and refractory severe bleeding prior to randomization; OR
  • Near drowning in ice water with patient core temperature ≤32 °C on presentation; OR
  • Patient is pregnant; OR
  • Patient participation in a concurrent interventional trial whose protocol, in the judgment of the THAPCA investigators, prevents effective application of one or both THAPCA therapeutic treatment arms, or otherwise significantly interferes with carrying out the THAPCA protocol; OR
  • Patient is newborn with acute birth asphyxia; OR

    _ Patient cared for in a neonatal intensive care unit (NICU) after arrest (ie, would not be admitted to PICU); OR

  • Patient has sickle cell anemia; OR
  • Patient known to have pre-existing cryoglobulinemia; OR
  • Central nervous system tumor with ongoing chemotherapy or radiation therapy; OR
  • Chronic hypothermia secondary to hypovolemic, pituitary, or related condition for which body temperature is consistently below 37 °C ; OR progressive degenerative encephalopathy; OR
  • Any condition in which direct skin surface cooling would be contraindicated, such as large burns, decubitus ulcers, cellulitis, or other conditions with disrupted skin integrity (NOTE: patients with open chest CPR should be included but placement of cooling mattresses will be modified as needed); OR
  • Previous enrollment in the THAPCA Trials.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00878644

  Hide Study Locations
Locations
United States, Alabama
The Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
University of Arizona at Tucson
Tucson, Arizona, United States, 85724
United States, California
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354
University of California Los Angeles
Los Angeles, California, United States, 90095
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90028
Children's Hospital of Orange County
Orange, California, United States, 92868
University of California San Francisco
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital of Denver/University of Colorado
Denver, Colorado, United States, 80045
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Children's Hospital of Atlanta/Emory University
Atlanta, Georgia, United States, 30306
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Children's Center
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan, Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, New York
Children's Hospital of New York - Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Duke Children's Hospital
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Children
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital in Columbus
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philidelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
LeBonheur Children's Hospital - University of Tennessee at Memphis
Memphis, Tennessee, United States, 38105
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
University of Texas Health Sciences Center of San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
United States, Washington
Seatlle Children's Hospital
Seattle, Washington, United States, 98105
United States, Wisconsin
Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Frank W Moler, MD, MS University of Michigan
Principal Investigator: Michael Dean, MD, MBA University of Utah
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Frank W. Moler, M.D, M.S, Professor of Pediatrics, University of Michigan
ClinicalTrials.gov Identifier: NCT00878644     History of Changes
Other Study ID Numbers: 619, U01HL094339
Study First Received: April 8, 2009
Last Updated: February 27, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Cardiac Arrest
Cardiopulmonary Arrest
Pediatric Cardiac Arrest
VABS
Vineland Adaptive Behavior Survey
POPC/PCPC
hypoxic-ichemic encephalopathy

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

ClinicalTrials.gov processed this record on September 22, 2014