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Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00797680
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : January 18, 2016
National Institute of Neurological Disorders and Stroke (NINDS)
Laerdal Medical
Information provided by (Responsible Party):
Ericka Fink, University of Pittsburgh

Brief Summary:
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 or disease Intervention/treatment Phase
Cardiac Arrest Brain Injury Other: 72 hours hypothermia Other: 24 hours hypothermia Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest
Study Start Date : October 2008
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 72 hours hypothermia
72 hours hypothermia
Other: 72 hours hypothermia
72 hours mild hypothermia (33 +/1 1 degree Celsius)

Experimental: 24 hours hypothermia
24 hours hypothermia
Other: 24 hours hypothermia
24 hours mild hypothermia (33 +/1 1 degree Celsius)

Primary Outcome Measures :
  1. Degree of brain injury as measured by serum and urine biomarkers and Magnetic Resonance Spectroscopy [ Time Frame: hospital discharge ]

Secondary Outcome Measures :
  1. Frequency of adverse events [ Time Frame: 30 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00797680

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United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Neurological Disorders and Stroke (NINDS)
Laerdal Medical
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Principal Investigator: Ericka L Fink, MD University of Pittsburgh
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Responsible Party: Ericka Fink, Associate Professor, Pediatric Critical Care Medicine, University of Pittsburgh Identifier: NCT00797680    
Other Study ID Numbers: ef1
K23NS065132 ( U.S. NIH Grant/Contract )
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Keywords provided by Ericka Fink, University of Pittsburgh:
Pediatric cardiac arrest
Additional relevant MeSH terms:
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Brain Injuries
Heart Arrest
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes