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Completed

NCT Number: NCT00868101

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

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

General Hospital of Ribeirao Preto, Sao Paulo University

Ribeirão Preto, São Paulo, 55, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischemic preconditioning

Procedure

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

Primary outcomes

  1. 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.

  2. Interleucine 8

    Time frame: 24 hours

    Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method

Secondary outcomes

  1. 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.

  2. Troponin I

    Time frame: 24 hours

    Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 24, 2009
Registry last updated
Jan 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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