NCT00556361

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2004

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2007

Completed
Last Updated

November 12, 2007

Status Verified

November 1, 2007

First QC Date

November 9, 2007

Last Update Submit

November 9, 2007

Conditions

Ventricular Septal Defect

Outcome Measures

Primary Outcomes (2)

  • To compare expression of serum markers of CNS injury

    within 48 hours

  • to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.

    within 48 hours

Secondary Outcomes (1)

  • to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls

    one month

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: saline

2

EXPERIMENTAL
Drug: ketamine

Interventions

salineDRUG

2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass

1
ketamineDRUG

2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

2

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • less than one year of age
  • undergoing cardiac surgery for repair of ventricular septal defect
  • requiring cardiopulmonary bypass
  • not requiring retrogrades cerebral perfusion

You may not qualify if:

  • Downs Syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Related Publications (1)

  • 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.

    PMID: 21926656DERIVED

MeSH Terms

Conditions

Heart Septal Defects, Ventricular

Interventions

Sodium ChlorideKetamine

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Adnan T Bhutta, MD

    Arkansas Children's Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2007

First Posted

November 12, 2007

Study Start

July 1, 2004

Study Completion

November 1, 2007

Last Updated

November 12, 2007

Record last verified: 2007-11

Locations

US(1)