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Use of Ketamine Prior to Cardiopulmonary Bypass in Children

NCT ID: NCT00556361

Last Updated: 2007-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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Conditions

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Ventricular Septal Defect

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

Interventions

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saline

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

Intervention Type DRUG

ketamine

2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Principal Investigators

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Adnan T Bhutta, MD

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Hospital Research Institute

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21926656 (View on PubMed)

Other Identifiers

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CUMG

Identifier Type: -

Identifier Source: secondary_id

28781 Bhutta

Identifier Type: -

Identifier Source: org_study_id