Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery

NCT ID: NCT01311310

Last Updated: 2012-05-01

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-12-31

Brief Summary

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This study is conducted in order to evaluate the effect of remote ischemic preconditioning on children undergoing cardiac surgery, especially focusing on possible differences according to preoperative cyanosis.

Detailed Description

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Conditions

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Cyanosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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remote ischemic preconditioning

Group Type EXPERIMENTAL

RIPC (remote ischemic preconditioning)

Intervention Type OTHER

RIPC will be performed by four 5-min cycles of lower limb ischemia and 5 in reperfusion using blood-pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure measured via arterial line.

Interventions

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RIPC (remote ischemic preconditioning)

RIPC will be performed by four 5-min cycles of lower limb ischemia and 5 in reperfusion using blood-pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure measured via arterial line.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* open heart surgery under cardiopulmonary bypass: ventricular septal defect, tetralogy of Fallot

Exclusion Criteria

* chromosomal defect
* airway and parenchymal lung disease blood disorder
* isolated atrail septal defect
* immunodeficiency
Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

Seoul national university hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H-0907-028-286

Identifier Type: -

Identifier Source: org_study_id

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