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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preconditioning | Experimental | Children who received the preconditioning stimulus |
|
| Control | No Intervention | Children who did not receive the preconditioning stimulus |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Interleucine 8 | Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| NT-proBNP | Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay. | 24 hours |
| Troponin I | Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Paula CP Carlotti, 1 | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Ribeirao Preto, Sao Paulo University | Ribeirão Preto | São Paulo | 55 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preconditioning | Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus. |
| FG001 | Control | Children who did not receive the preconditioning stimulus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preconditioning | Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | NT-proBNP | Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay. | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
|
1 month
We searched for adverse events secondary to preconditioning in the leg, such ischemic lesions, nerve palsy or thrombus
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preconditioning | Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus. |
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Small number of subjects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcos Alves Pavione | Universidade de Sao Paulo | 55 79 9199 9576 | mapavione@hotmail.com |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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|
| 24 hours |
| BG001 |
| Control |
Children who did not receive the preconditioning stimulus |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| Primary | Interleucine 8 | Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
|
|
|
| Secondary | Troponin I | Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay. | Posted | Mean | Standard Deviation | pg/mL | 24 hours |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control | Children who did not receive the preconditioning stimulus | 0 | 10 | 0 | 10 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |