Use of Ketamine Prior to Cardiopulmonary Bypass in Children

This study has been completed.

Sponsor:

Information provided by:

Arkansas Children's Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT00556361

First received: November 9, 2007

Last updated: NA

Last verified: November 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

November 9, 2007

Last Updated Date

November 9, 2007

Start Date ^ICMJE

July 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To compare expression of serum markers of CNS injury [ Time Frame: within 48 hours ]
to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls. [ Time Frame: within 48 hours ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls [ Time Frame: one month ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Official Title ^ICMJE

Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Brief Summary

To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Ventricular Septal Defect

Intervention ^ICMJE

Drug: saline
2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
Drug: ketamine
2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

Study Arm (s)

Placebo Comparator: 1
Intervention: Drug: saline
Experimental: 2
Intervention: Drug: ketamine

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 1 Year

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00556361

Other Study ID Numbers ^ICMJE

28781 Bhutta, CUMG

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Arkansas Children's Hospital Research Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Adnan T Bhutta, MD

Arkansas Children's Hospital Research Institute

Information Provided By

Arkansas Children's Hospital Research Institute

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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