Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Laerdal Medical
Children's Hospital of Pittsburgh
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00797680
First received: November 24, 2008
Last updated: August 5, 2011
Last verified: August 2011
  Purpose

In this study, children who survive cardiac arrest will be evaluated whether 24 or 72 hours of whole body hypothermia (cooling) during recovery is better to help prevent brain injury and improve outcome. The investigators will also test the safety of cooling patients for 24 and 72 hours. The investigators hypothesize that 72 hours of cooling will be more beneficial than 24 hours without compromising safety.


Condition Intervention Phase
Cardiac Arrest
Brain Injury
Other: 72 hours hypothermia
Other: 24 hours hypothermia
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Degree of brain injury as measured by serum and urine biomarkers and Magnetic Resonance Spectroscopy [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: October 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 72 hours hypothermia Other: 72 hours hypothermia
72 hours mild hypothermia (33 +/1 1 degree Celsius)
Experimental: 24 hours hypothermia Other: 24 hours hypothermia
24 hours mild hypothermia (33 +/1 1 degree Celsius)

Detailed Description:

Cooling has been shown to decrease the amount of brain injury that can occur after heart attacks in adults and in newborn babies with birth asphyxia (a lack of blood flow and oxygen to the fetus). It is unknown if cooling is effective in children after cardiac arrest. However, cooling is recommended by the American Heart Association as a "consideration" for use in children after cardiac arrest to prevent brain injury and has been used by doctors in our intensive care unit since 2002.

Children will be randomly assigned to receive either 24 or 72 hours of cooling and compare the results of 1) blood-and urine derived markers of brain injury, and 2) brain magnetic resonance imaging and spectroscopy (MRI and MRS), which measures the anatomy and chemical patterns in the brain without using ionizing radiation, between the two groups of patients with 24 or 72 hours of cooling. We will also evaluate if cooling has any effect on patient outcome and quality of life at 6 months and one year using telephone or mail questionnaires.

A child may take part in this research study if he or she had a cardiac arrest, received help with breathing and chest compressions to get a spontaneous heart rate by a health care worker, and remains unconscious in the intensive care unit (ICU). The attending physician in the ICU has already decided to cool your child to provide protection for his or her brain function.

Children invited to participate in this study also are between 1 week and 17 years of age, have access tubes already in place in an artery or vein for blood draws, a urine catheter, are able to undergo MRI and MRS brain scans, and, if female, cannot be pregnant.

Patients can not have had an acute brain injury from other causes (ex., meningitis, trauma), hemorrhage (excess bleeding from any site), congenital heart disease, do not resuscitate status, are undergoing a brain death examination, or have a known coagulation defect that makes them bleed more easily. The study will be performed on a total of 40 children strictly in this hospital.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chest compressions by a health care worker Age 1 wk - 17 yr ROSC attained PICU attending decides to cool Central venous or arterial catheter Glasgow Coma Score ≤ 8

Exclusion Criteria:

Other acute brain injury (TBI, meningitis) Do not resuscitate status Pregnancy Absolute contraindication to MRI Brain death evaluation Metabolic disorder Active hemorrhage Pre-existing coagulation defect

  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: NCT00797680

Contacts
Contact: Ericka L Fink, MD 412-692-5164 finkel@ccm.upmc.edu

Locations
United States, Pennsylvania
Children's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ericka L Fink, MD         
Sponsors and Collaborators
University of Pittsburgh
Laerdal Medical
Children's Hospital of Pittsburgh
Investigators
Principal Investigator: Ericka L Fink, MD Children's Hospital of Pittsburgh
  More Information

No publications provided

Responsible Party: Ericka L. Fink, MD, Children's Hospital of Pittsburgh of UPMC
ClinicalTrials.gov Identifier: NCT00797680     History of Changes
Other Study ID Numbers: ef1
Study First Received: November 24, 2008
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Pediatric cardiac arrest

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Brain Injuries
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 23, 2014