Congenital Heart Disease
Conditions
Keywords
ischemic, preconditioning, congenital heart disease
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).
Interventions
PROCEDURERemote ischemic preconditioning
Remote ischemic preconditioning was induced by four 5-minutes cycles of lower limb ischemia and reperfusion using a blood pressure cuff
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Control Children who did not receive the preconditioning stimulus | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Control | Preconditioning | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 12 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 6.6 years STANDARD_DEVIATION 4.6 | 7.9 years STANDARD_DEVIATION 6.6 | 7.3 years STANDARD_DEVIATION 5.7 |
| Region of Enrollment Brazil | 10 participants | 12 participants | 22 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preconditioning | IkB-alpha Expression | 4.1 units on a scale | Standard Deviation 3.7 |
| Control | IkB-alpha Expression | 3.6 units on a scale | Standard Deviation 1.7 |
Primary
Interleucine 8
Quantification of interlecine 8 (a pro-inflammatory protein) using the ELISA method
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preconditioning | Interleucine 8 | 20.8 pg/mL | Standard Deviation 17.2 |
| Control | Interleucine 8 | 32.2 pg/mL | Standard Deviation 19.4 |
Secondary
NT-proBNP
Plasma concentration of the amino-terminal of B-type natriuretic peptite (NT-proBNP)was measured by enzyme electrochemiluminescence immunoassay.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preconditioning | NT-proBNP | 8.565 pg/mL | Standard Deviation 5.155 |
| Control | NT-proBNP | 12.681 pg/mL | Standard Deviation 5.822 |
Secondary
Troponin I
Seric concentration of troponin I, a myocardial cell injury marker. We measured by solid-phase chemiluminescence immunoassay.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preconditioning | Troponin I | 33.7 pg/mL | Standard Deviation 21.5 |
| Control | Troponin I | 22.3 pg/mL | Standard Deviation 19.3 |