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| Sponsors and Collaborators: |
University of Pittsburgh Laerdal Medical Children's Hospital of Pittsburgh |
|---|---|
| Information provided by: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00797680 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest |
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 72 hours hypothermia: Experimental |
Other: 72 hours hypothermia
72 hours mild hypothermia (33 +/1 1 degree Celsius)
|
| 24 hours hypothermia: Experimental |
Other: 24 hours hypothermia
24 hours mild hypothermia (33 +/1 1 degree Celsius)
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ericka L Fink, MD | 412-692-5164 | finkel@ccm.upmc.edu |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Ericka L Fink, MD | |
| Principal Investigator: | Ericka L Fink, MD | Children's Hospital of Pittsburgh |
More Information
| Responsible Party: | Children's Hospital of Pittsburgh ( Ericka L. Fink, MD ) |
| Study ID Numbers: | ef1 |
| Study First Received: | November 24, 2008 |
| Last Updated: | November 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00797680 |
| Health Authority: | United States: Institutional Review Board |
|
Pediatric cardiac arrest |
|
Craniocerebral Trauma Signs and Symptoms Hypothermia Heart Diseases Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Heart Arrest Trauma, Nervous System Brain Diseases Brain Injuries |
|
Nervous System Diseases Cardiovascular Diseases Body Temperature Changes |
