Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest
Primary Purpose
Cardiac Arrest, Brain Injury
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
72 hours hypothermia
24 hours hypothermia
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring Pediatric cardiac arrest
Eligibility 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
Sites / Locations
- Children's Hospital of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
72 hours hypothermia
24 hours hypothermia
Arm Description
72 hours hypothermia
24 hours hypothermia
Outcomes
Primary Outcome Measures
Degree of brain injury as measured by serum and urine biomarkers and Magnetic Resonance Spectroscopy
Secondary Outcome Measures
Frequency of adverse events
Full Information
NCT ID
NCT00797680
First Posted
November 24, 2008
Last Updated
January 15, 2016
Sponsor
University of Pittsburgh
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Laerdal Medical
1. Study Identification
Unique Protocol Identification Number
NCT00797680
Brief Title
Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest
Official Title
Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Laerdal Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Brain Injury
Keywords
Pediatric cardiac arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
72 hours hypothermia
Arm Type
Experimental
Arm Description
72 hours hypothermia
Arm Title
24 hours hypothermia
Arm Type
Experimental
Arm Description
24 hours hypothermia
Intervention Type
Other
Intervention Name(s)
72 hours hypothermia
Intervention Description
72 hours mild hypothermia (33 +/1 1 degree Celsius)
Intervention Type
Other
Intervention Name(s)
24 hours hypothermia
Intervention Description
24 hours mild hypothermia (33 +/1 1 degree Celsius)
Primary Outcome Measure Information:
Title
Degree of brain injury as measured by serum and urine biomarkers and Magnetic Resonance Spectroscopy
Time Frame
hospital discharge
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ericka L Fink, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34271122
Citation
Kernan KF, Berger RP, Clark RSB, Scott Watson R, Angus DC, Panigrahy A, Callaway CW, Bell MJ, Kochanek PM, Fink EL, Simon DW. An exploratory assessment of serum biomarkers of post-cardiac arrest syndrome in children. Resuscitation. 2021 Oct;167:307-316. doi: 10.1016/j.resuscitation.2021.07.007. Epub 2021 Jul 14.
Results Reference
derived
PubMed Identifier
32653571
Citation
Fink EL, Wisnowski J, Clark R, Berger RP, Fabio A, Furtado A, Narayan S, Angus DC, Watson RS, Wang C, Callaway CW, Bell MJ, Kochanek PM, Bluml S, Panigrahy A. Brain MR imaging and spectroscopy for outcome prognostication after pediatric cardiac arrest. Resuscitation. 2020 Dec;157:185-194. doi: 10.1016/j.resuscitation.2020.06.033. Epub 2020 Jul 9.
Results Reference
derived
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Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest
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