Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-IH [In Hospital] Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frank W. Moler, M.D, M.S, University of Michigan
ClinicalTrials.gov Identifier:
NCT00880087
First received: April 10, 2009
Last updated: August 6, 2014
Last verified: August 2014
  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 in the hospital.


Condition Intervention Phase
Cardiac Arrest
Procedure: Therapeutic Hypothermia
Procedure: 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 (In 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 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
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.
Other Name: Therapeutic hypothermia
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.
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 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.

  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: NCT00880087

Contacts
Contact: Frank W Moler, MD, MS 734-764-5302 fmoler@umich.edu
Contact: Brittan Browning, MS, RD, CCRC 801-587-7568 brittan.browning@hsc.utah.edu

  Hide Study Locations
Locations
United States, Alabama
The Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
Contact: Jeffery Alten, MD    205-939-9387    jalten@peds.uab.edu   
Contact: Kendra Smith, BS, MS    205-996-3316    ksmith@peds.uab.edu   
Principal Investigator: Jeffrey Alten, MD         
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Heidi Dalton, MD    602-546-1784    hdalton@phoenixchildrens.com   
Contact: Aimee La Bell, MSN    602-933-5307    alabell@phoenixchildrens.com   
Principal Investigator: Heidi Dalton, MD         
United States, California
Loma Linda University Children's Hospital Recruiting
Loma Linda, California, United States, 92354
Contact: Mudit Mathur, MD    909-558-0303    mmathur@llu.edu   
Contact: Jennifer Newcombe    909-558-4818    jnewcombe@llu.edu   
Principal Investigator: Mudit Mathur, MD         
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Rick Harrison, MD    310-825-6752    RickHarrison@mednet.ucla.edu   
Contact: Margaret Villa, BS, ASN    323-361-6329    margvilla@chla.usc.edu   
Principal Investigator: Rick Harrison, MD         
Children's Hospital of Los Angeles Recruiting
Los Angeles, California, United States, 90028
Contact: Christopher Newth, MD    323-361-2117    cnewth@chla.usc.edu   
Contact: Margaret Villa, BS, ASN    323-361-6329    margvilla@chla.usc.edu   
Principal Investigator: Christopher Newth, MD         
Children's Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact: Adam Schwartz, MD    714-532-8620    aschwarz@choc.org   
Contact: Ofelia Vargas-Shiraishi, BS    714-532-8375    ovargas@choc.org   
Principal Investigator: Adam Schwartz, MD         
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Patrick McQuillen       mcquillp@peds.ucsf.edu   
Contact: Laurel Haeusslein    415-502-7094    laurel.haeusslein@ucsf.edu   
Principal Investigator: Patrick McQuillen, MD         
United States, District of Columbia
Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: John Berger, MD    202-476-3724    jberger@cnmc.org   
Contact: Elyse Tomanio, BSN    202-476-3389    etomanio@childrensnational.org   
Principal Investigator: John Berger, MD         
United States, Georgia
Children's Hospital of Atlanta/Emory University Recruiting
Atlanta, Georgia, United States, 30306
Contact: Nga Pham, MD       nga.pham@choa.org   
Contact: Cheryl Stone, RN    404-785-6454    cheryll.stone@choa.org   
Principal Investigator: Nga Pham, MD         
United States, Indiana
Riley Children's Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Mark R Rigby, MD    317-948-7185    mrigby@iupui.edu   
Principal Investigator: Mark R Rigby, MD         
United States, Kentucky
Kosair Children's Hospital Recruiting
Louisville, Kentucky, United States, 40202
Contact: Melissa Porter, MD       mbport04@gwise.louisville.edu   
Contact: Missi Thomas, RN    502-629-5606    mcthom12@gwise.louisville.edu   
Principal Investigator: Melissa Porter, MD         
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Utpal S Bhalala, MD    410-955-6412    ubhalal1@jhmi.edu   
Contact: Bhavana Shivakumar, BA    443-287-1650    bshivak1@jhu.edu   
Principal Investigator: Utpal S Bhalala, MD         
United States, Michigan
University of Michigan, Mott Children's Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Frank Moler, MD, MS    734-764-5302    fmoler@umich.edu   
Contact: Monica Weber, RN, CCRP    734-763-7131    monij@umich.edu   
Principal Investigator: Frank Moler, MD         
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Kathleen Meert, MD    313-745-5891    kmeert@med.wayne.edu   
Contact: Ann Pawluska, RN    313-966-5395    apawlusz@med.wayne.edu   
Principal Investigator: Kathleen Meert, MD         
United States, Missouri
Washington University in St. Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jose Pineda, MD, MSC    314-454-2545    pineda_j@kids.wustl.edu   
Contact: Tina Day    314-747-5579    day_t@kids.wustl.edu   
Principal Investigator: Jose Pineda, MD         
United States, North Carolina
Duke Children's Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: George Ofori-Amanfo, MD, BSc.HB    919-681-7692    George.ofori@duke.edu   
Contact: Samatha Wrenn, BA, AAS-BA    919-681-2554    samantha.wrenn@dm.duke.edu   
Principal Investigator: George Ofori-Amanfo, MD, BSc.HB         
United States, Ohio
Nationwide Children's Hospital in Columbus Recruiting
Columbus, Ohio, United States, 43205
Contact: Eric Lloyd, MD    614-722-3436    eric.lloyd@nationwidechildrens.org   
Contact: Karen Carter    614-722-2575    karen.carter@nationwidechildrens.org   
Principal Investigator: Eric Lloyd, MD         
United States, Pennsylvania
Penn State Children's Hospital Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Neal Thomas, MD    717-531-0809    nthomas@hmc.psu.edu   
Contact: Debbie Spear    717-531-5193    dspear@hmc.psu.edu   
Principal Investigator: Neal Thomas, MD         
Children's Hospital of Philidelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alexis Topjian, MD    215-590-3915    topjian@email.chop.edu   
Contact: Carolann Twelves, BSN    215-590-4936    twelvesc@email.chop.edu   
Principal Investigator: Alexis Topjian, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Erica Fink, MD    412-692-6568    finkEL@ccm.upmc.edu   
Contact: Alan Abraham, BA, CCRC    412-692-7626    abraac@upmc.edu   
Principal Investigator: Erica Fink, MD         
United States, Tennessee
LeBonheur Children's Hospital - University of Tennessee at Memphis Recruiting
Memphis, Tennessee, United States, 38105
Contact: Samir Shah, MBBS, FRCPC    901-287-5198    sshah7@uthsc.edu   
Contact: Alina Nico West, MD, phD    901-287-5301    nico.west@lebonheur.org   
Principal Investigator: Samir Shah, MD         
United States, Texas
Children's Medical Center Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Josh Koch, MD    214-456-0441    josh.koch@childrens.com   
Contact: Angelia Riley, MS    214-456-8072    Angelia.Riley@childrens.com   
Principal Investigator: Josh Koch, MD         
University of Texas Health Sciences Center of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Theodore Wu, MD    210-562-5816    wut@uthscsa.edu   
Contact: Holly Dibrell    210-562-5816    dibrell@uthscsa.edu   
Principal Investigator: Theodore Wu, MD         
United States, Utah
Primary Children's Medical Center Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Jill Sweney, MD    801-587-7572    Jill.Sweney@hsc.utah.edu   
Contact: Kammy Jacobson    801-587-7450    kammy.jacobsen@hsc.utah.edu   
Principal Investigator: Jill Sweney, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seatle, Washington, United States, 98105
Contact: Jerry Zimmerman, MD    206-987-3862    jerry.zimmerman@seattlechildrens.org   
Contact: Stephanie Hamilton, BA, BSN    206-884-4558    stephanie.hamilton@seattlechildrens.org   
Principal Investigator: Jerry Zimmerman, MD         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: James Hutchison, MD, FRCPC    416-813-5822    Jamie.hutchison@sickkids.ca   
Contact: Judith Van Huyse, RN    416-813-7654 ext 1939    judith.vanhuyse@sickkids.ca   
Principal Investigator: James Hutchison, MD, FRCPC         
United Kingdom
Birmingham Children's Hospital Recruiting
Birmingham, United Kingdom, B4 6NH
Contact: Barney Schofield, MD    011 44 121 333 9652    Barney.scholefield@bch.nhs.uk   
Contact: Alison Jones    011 44 121 333 9684    Alison.Jones5@bch.nhs.uk   
Principal Investigator: Bareny Schofield, MD         
Bristol Royal Hospital for Children Recruiting
Bristol, United Kingdom, BS2 8BJ
Contact: Margrid Schindler, MD    011 44 117 342 8843    Margrid.Schindler@UHBristol.nhs.uk   
Contact: Sarah Potter    011 44 117 342 8346    Sarah.potter@uhbristol.nhs.uk   
Principal Investigator: Margrid Schindler, MD         
University of Hampton Recruiting
Hampton, United Kingdom, SO16 6YD
Contact: John Pappachan, MD    011 44 238 120 6972 ext 4773    jvp@soton.ac.uk   
Contact: Rachel Fowler    011 44 238 120 4989    rachel.fowler@nhs.uhs.uk   
Principal Investigator: John Pappachan, MD         
Alder Hey Children's Hospital Recruiting
Liverpool, United Kingdom, L12 2AP
Contact: Paul Bannes, MD       Alice.Wood@alderhey.nhs.uk   
Contact: Alice Wood    011 44 151 293 3552    Alice.Wood@alderhey.nhs.uk   
Principal Investigator: Paul Baines, MD         
Evalina Children's at Guys's and St. Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Andrew Nyman, MD    011 44 207 188 7188 ext 53799    andrew.nyman@gtt.nhs.uk   
Contact: Julia Harris       julia.harris@gstt.nhs.uk   
Principal Investigator: Andrew Nyman, MD         
Great Ormand Street Hospital Recruiting
London, United Kingdom, WC1N 3JH
Contact: Sophie Skellett, MD    011 44 207 813 8117    sophie.skellett@gosh.nhs.uk   
Contact: Polly Payne    011 44 207 405 9200 ext 5459    polly.payne@gosh.nhs.uk   
Principal Investigator: Sophie Skellett, MD         
Royal Manchester Children's Hospital Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Stephen Playfor, MD    011 44-161-701-8045    stephen.playfor@cmft.nhs.uk   
Contact: Philip Hudnott    011 44 161 701 8027    philip.hudnott@cmft.nhs.uk   
Principal Investigator: Stephen Playfor, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Frank Moler, MD University of Michigan
Principal Investigator: Michael Dean, MD 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: NCT00880087     History of Changes
Other Study ID Numbers: 620, U01HL094345
Study First Received: April 10, 2009
Last Updated: August 6, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 27, 2014