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

Study Overview
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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).

Official Title
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The Use of Remote Ischemic Preconditioning Applied in Child the Day Before Open Heart Surgery With Extracorporeal Circulation to Correct Congenital Heart Diseases (the Second Window Effect)

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Procedure: Remote ischemic preconditioning


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preconditioning<br>Children who received the preconditioning stimulus | Procedure: Remote ischemic preconditioning<br>* Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff<br>* Other names: Register number provided by hospital;|
| No Intervention: Control<br>Children who did not receive the preconditioning stimulus | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IkB-alpha Expression | Expressure of gene of an inhibitory protein called kappa-B alpha (IkB-alpha). Inhibits the inflammatory response protein called kappa-B nuclear factor. To measure that expression we used a real time protein chain reaction (RT-PCR), always comparing with an endogenous protein expression (this way, the encountered value is apresented in arbitraries units, that means how much times the expression of the protein IkB-alpha is bigger than the endogenous protein that present a invariable value. | 24 hours | 
| Interleucine 8 | Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP | Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay. | 24 hours | 
| Troponin I | Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic, preconditioning, congenital heart disease