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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00868101
First Posted: March 24, 2009
Last Update Posted: January 9, 2012
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.
Information provided by (Responsible Party):
Marcos Alves Pavione, University of Sao Paulo
March 23, 2009
March 24, 2009
August 3, 2011
January 9, 2012
January 9, 2012
January 2008
November 2009   (Final data collection date for primary outcome measure)
  • 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
Morbidity and inflammatory response [ Time Frame: 0-2 days ]
Complete list of historical versions of study NCT00868101 on ClinicalTrials.gov Archive Site
  • 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.
Heart Injury [ Time Frame: 0 - 2 days ]
Not Provided
Not Provided
 
The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
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)
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.
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).
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Congenital Heart Disease
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
Other Names:
  • Inicial letters of the full name
  • Register number provided by hospital
  • Experimental: Preconditioning
    Children who received the preconditioning stimulus
    Intervention: Procedure: Remote ischemic preconditioning
  • No Intervention: Control
    Children who did not receive the preconditioning stimulus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
December 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
1 Month to 2 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00868101
MAP01
Yes
Not Provided
Not Provided
Marcos Alves Pavione, University of Sao Paulo
University of Sao Paulo
Not Provided
Study Director: Ana Paula CP Carlotti, 1 University of Sao Paulo
University of Sao Paulo
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP