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.|
|ClinicalTrials.gov Identifier: NCT00797680|
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : January 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest Brain Injury||Other: 72 hours hypothermia Other: 24 hours hypothermia||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- Degree of brain injury as measured by serum and urine biomarkers and Magnetic Resonance Spectroscopy [ Time Frame: hospital discharge ]
- Frequency of adverse events [ Time Frame: 30 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT00797680
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Ericka L Fink, MD||University of Pittsburgh|