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
  Purpose

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


Condition Intervention Phase
Ventricular Septal Defect
Drug: saline
Drug: ketamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 24
Study Start Date: July 2004
Study Completion Date: November 2007
Arms Assigned Interventions
Placebo Comparator: 1 Drug: saline
2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
Experimental: 2 Drug: ketamine
2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556361

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Adnan T Bhutta, MD Arkansas Children's Hospital Research Institute
  More Information

No publications provided by Arkansas Children's Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00556361     History of Changes
Other Study ID Numbers: 28781 Bhutta, CUMG
Study First Received: November 9, 2007
Last Updated: November 9, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014