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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:
Information provided by (Responsible Party):
Marcos Alves Pavione, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00868101
First received: March 23, 2009
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Congenital Heart Disease
 Procedure: Remote ischemic preconditioning
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • IkB-alpha Expression [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method


Secondary Outcome Measures:
  • NT-proBNP [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.


Enrollment: 22
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preconditioning
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
Other Names:
  • Inicial letters of the full name
  • Register number provided by hospital
No Intervention: Control
Children who did not receive the preconditioning stimulus

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   1 Month to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868101

Locations
Brazil
General Hospital of Ribeirao Preto, Sao Paulo University
Ribeirao Preto, Sao Paulo, Brazil, 55
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Ana Paula CP Carlotti, 1 University of Sao Paulo
  More Information

Additional Information:
General Hospital of University of Sao Paulo at Ribeirao Preto  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Marcos Alves Pavione, mester, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00868101     History of Changes
Other Study ID Numbers: MAP01
Study First Received: March 23, 2009
Results First Received: August 3, 2011
Last Updated: December 2, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
ischemic
preconditioning
congenital heart disease

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 21, 2013