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

Phase 1

Completed

• Conditions: Congenital Heart Disease
• Interventions: Procedure: Remote ischemic preconditioning

• Registration Number: NCT00868101
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

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).

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-23
• Study First Posted: 2009-03-24
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Results First Submitted: 2011-08-03
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-02
• Last Update Submitted: 2011-12-02
• Results First Posted: 2012-01-09
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preconditioning	Remote ischemic preconditioning	Children who received the preconditioning stimulus

Primary Outcome Measures

Name	Time	Method
IkB-alpha Expression	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	24 hours	Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method

Secondary Outcome Measures

Name	Time	Method
NT-proBNP	24 hours	Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.
Troponin I	24 hours	Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.

Trial Locations

Locations (1)

General Hospital of Ribeirao Preto, Sao Paulo University; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil