The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||November 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|