We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Ketamine Prior to Cardiopulmonary Bypass in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556361
First Posted: November 12, 2007
Last Update Posted: November 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Arkansas Children's Hospital Research Institute
  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: Triple (Participant, Care Provider, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 9, 2007
First Posted: November 12, 2007
Last Update Posted: November 12, 2007
Last Verified: November 2007

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
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