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

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Remote ischemic preconditioning
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease focused on measuring ischemic, preconditioning, congenital heart disease

Eligibility Criteria

1 Month - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Ribeirao Preto, Sao Paulo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preconditioning

Control

Arm Description

Children who received the preconditioning stimulus

Children who did not receive the preconditioning stimulus

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2009
Last Updated
December 2, 2011
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00868101
Brief Title
The Effect of Remote Ischemic Preconditioning Applied in Children the Day Before Open Heart Surgery
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)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
ischemic, preconditioning, congenital heart disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preconditioning
Arm Type
Experimental
Arm Description
Children who received the preconditioning stimulus
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children who did not receive the preconditioning stimulus
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic preconditioning
Other Intervention Name(s)
Inicial letters of the full name, Register number provided by hospital
Intervention Description
Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff
Primary Outcome Measure Information:
Title
IkB-alpha Expression
Description
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.
Time Frame
24 hours
Title
Interleucine 8
Description
Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
NT-proBNP
Description
Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.
Time Frame
24 hours
Title
Troponin I
Description
Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Paula CP Carlotti, 1
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
General Hospital of Ribeirao Preto, Sao Paulo University
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
55
Country
Brazil

12. IPD Sharing Statement

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