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

Congenital Heart Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868101
• Other study ID #: MAP01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 23, 2009
• Last updated: December 2, 2011
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 2 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Brazil	General Hospital of Ribeirao Preto, Sao Paulo University	Ribeirao Preto	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IkB-alpha Expression	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.	24 hours	Yes
Primary	Interleucine 8	Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method	24 hours	Yes
Secondary	NT-proBNP	Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.	24 hours	Yes
Secondary	Troponin I	Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.	24 hours	Yes

External Links

•   General Hospital of University of Sao Paulo at Ribeirao Preto