Cardiac Surgery, Myocardial Injury
Conditions
Keywords
RIPC, cyclosporine, ischemia reperfusion injury, MDA, calcium cytosol, tetralogy Fallot, mitochondrial edema, infundibulum
Brief summary
The study aimed to evaluate the combined effects of cyclosporine and remote ischemic preconditioning on MDA, calcium cytosol concentration, and mitochondrial edema in tetralogy Fallot patients undergoing corrective surgery.
Detailed description
Forty patients undergoing tetralogy Fallot corrective surgery were randomized to RIPC and cyclosporine (n=20) and control (n=20). Cyclosporin was administered 2 hour pre induction of anesthesia with the dose of 3 mg/kg body weight intravenously. RIPC was performed preoperatively after induction of anesthesia by inflating pressure cuff on the extremity 30 mmHg higher than systolic blood pressure of the patient for 5x5 minutes with 5 minutes reperfusion interval. Blood samples from coronary sinus and biopsies from the myocardial infundibulum were obtained three times at the condition of pre ischemic, ischemic, and reperfusion. MDA was measured from the blood samples, meanwhile calcium cytosol concentration and mitochondrial edema was measured from the biopsy samples.
Interventions
DRUGCyclosporin
Cyclosporin was administered intravenously with the dose of 3 mg/ kg body weight
PROCEDUREremote ischemic preconditioning
Performed by inflating pressure cuff on the extremity 30 mmHg higher than systolic blood pressure of the patient for 5x5 minutes with 5 minutes reperfusion interval
DRUGPlacebo
Intravenous placebo
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Tetralogy Fallot patient that is undergoing correction surgery * Has an ideal anatomy for corrective surgery, namely: Pulmonary artery size within normal limits (according to the kirklin table), Mc Goon ratio\> 1.5, Nakata index\> 200, normal coronary artery ostium and good biventricular function.
Exclusion criteria
* Patient refuses the procedure * Patient with acute kidney injury * Patient without lower extremity * Patient with cyclosporin allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Malondialdehyde (MDA) | 1 year | ROS level is determined by measuring MDA concentration (nmol/mL) |
| Calcium cytosol concentration | 1 year | Calcium concentration (nmol/mL) in cytosol is determined by ratiometric analysis on Fura Red- dyed heart cells. |
| Mitochondrial edema | 1 year | Mitochondrial edema (%) is measured by decreasing of optical density that indicates change in mitochondrial matrix volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac index | 1 year | Examined with echocardiography, unit of measurement is litres per minute per square metre (L/min/m2). |
| Troponin I | 1 year | Measured from venous blood, unit of measurement is nanograms per milliliter (ng/mL). |
| Creatine kinase- MB (CKMB) | 1 year | Measured from venous blood, unit of measurement is units per liter (IU/L). |
| Vasoactive inotropic score (VIS) | 1 year | VIS was calculated as: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min). |
Countries
Indonesia
Outcome results
None listed