The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery

NCT ID: NCT00868101

Last Updated: 2012-01-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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The study research is to analyse brief episodes of limb ischemia applied to children the day before open heart surgery as protection from myocardial injury induced by extracorporeal circulation.

Detailed Description

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Children undergoing repair of congenital heart defects were randomized to RIPC (remote ischemic preconditioning) or control treatment. RIPC was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff. Measurements of troponin I, brain natriuretic peptide, interleukines 8 and 10, real time PCR to NFKB and clinical parameters were obtained and compared postoperatively (4, 12, 24 and 48 hous after).

Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Preconditioning

Children who received the preconditioning stimulus

Group Type EXPERIMENTAL

Remote ischemic preconditioning

Intervention Type PROCEDURE

Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff

Control

Children who did not receive the preconditioning stimulus

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote ischemic preconditioning

Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff

Intervention Type PROCEDURE

Other Intervention Names

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Inicial letters of the full name Register number provided by hospital

Eligibility Criteria

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Inclusion Criteria

* 1 month to 2 years age
* waiting for open heart surgery in hospital
* 2008, january to march
* Rachs-1, except the 1 category

Exclusion Criteria

* genetic syndromes
* infected children
* immunodeficiency
* immunosuppressor use
* no parents permission
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Marcos Alves Pavione

mester

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana Paula CP Carlotti, 1

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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General Hospital of Ribeirao Preto, Sao Paulo University

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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MAP01

Identifier Type: -

Identifier Source: org_study_id

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