Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest
2 other identifiers
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 24, 2008
CompletedFirst Posted
Study publicly available on registry
November 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJanuary 18, 2016
January 1, 2016
5.5 years
November 24, 2008
January 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Degree of brain injury as measured by serum and urine biomarkers and Magnetic Resonance Spectroscopy
hospital discharge
Secondary Outcomes (1)
Frequency of adverse events
30 days
Study Arms (2)
72 hours hypothermia
EXPERIMENTAL72 hours hypothermia
24 hours hypothermia
EXPERIMENTAL24 hours hypothermia
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- Laerdal Medicalcollaborator
Study Sites (1)
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (2)
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.
PMID: 34271122DERIVEDFink 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.
PMID: 32653571DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ericka L Fink, MD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Pediatric Critical Care Medicine
Study Record Dates
First Submitted
November 24, 2008
First Posted
November 25, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2014
Study Completion
April 1, 2015
Last Updated
January 18, 2016
Record last verified: 2016-01