The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
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|ClinicalTrials.gov Identifier: NCT00868101|
Recruitment Status : Completed
First Posted : March 24, 2009
Results First Posted : January 9, 2012
Last Update Posted : January 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease||Procedure: Remote ischemic preconditioning||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||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)|
|Study Start Date :||January 2008|
|Primary Completion Date :||November 2009|
|Study Completion Date :||December 2009|
Children who received the preconditioning stimulus
Procedure: Remote ischemic preconditioning
Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff
No Intervention: Control
Children who did not receive the preconditioning stimulus
- IkB-alpha Expression [ Time Frame: 24 hours ]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.
- Interleucine 8 [ Time Frame: 24 hours ]Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method
- NT-proBNP [ Time Frame: 24 hours ]Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.
- Troponin I [ Time Frame: 24 hours ]Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868101
|General Hospital of Ribeirao Preto, Sao Paulo University|
|Ribeirao Preto, Sao Paulo, Brazil, 55|
|Study Director:||Ana Paula CP Carlotti, 1||University of Sao Paulo|