Use of Ketamine Prior to Cardiopulmonary Bypass in Children
Primary Purpose
Ventricular Septal Defect
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
saline
ketamine
Sponsored by
About this trial
This is an interventional prevention trial for Ventricular Septal Defect
Eligibility Criteria
Inclusion Criteria:
- less than one year of age
- undergoing cardiac surgery for repair of ventricular septal defect
- requiring cardiopulmonary bypass
- not requiring retrogrades cerebral perfusion
Exclusion Criteria:
- Downs Syndrome
Sites / Locations
- Arkansas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
To compare expression of serum markers of CNS injury
to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.
Secondary Outcome Measures
to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls
Full Information
NCT ID
NCT00556361
First Posted
November 9, 2007
Last Updated
November 9, 2007
Sponsor
Arkansas Children's Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00556361
Brief Title
Use of Ketamine Prior to Cardiopulmonary Bypass in Children
Official Title
Use of Ketamine Prior to Cardiopulmonary Bypass in Children
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Arkansas Children's Hospital Research Institute
4. Oversight
5. Study Description
Brief Summary
To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Septal Defect
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Description
2 mg/Kg IV within 5 minutes of cardiopulmonary bypass
Primary Outcome Measure Information:
Title
To compare expression of serum markers of CNS injury
Time Frame
within 48 hours
Title
to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.
Time Frame
within 48 hours
Secondary Outcome Measure Information:
Title
to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls
Time Frame
one month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
less than one year of age
undergoing cardiac surgery for repair of ventricular septal defect
requiring cardiopulmonary bypass
not requiring retrogrades cerebral perfusion
Exclusion Criteria:
Downs Syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan T Bhutta, MD
Organizational Affiliation
Arkansas Children's Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21926656
Citation
Bhutta AT, Schmitz ML, Swearingen C, James LP, Wardbegnoche WL, Lindquist DM, Glasier CM, Tuzcu V, Prodhan P, Dyamenahalli U, Imamura M, Jaquiss RD, Anand KJ. Ketamine as a neuroprotective and anti-inflammatory agent in children undergoing surgery on cardiopulmonary bypass: a pilot randomized, double-blind, placebo-controlled trial. Pediatr Crit Care Med. 2012 May;13(3):328-37. doi: 10.1097/PCC.0b013e31822f18f9.
Results Reference
derived
Learn more about this trial
Use of Ketamine Prior to Cardiopulmonary Bypass in Children
We'll reach out to this number within 24 hrs