Trials / Completed
CompletedNCT05691764
Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery
Effect of Cyclosporine and Remote Ischemic Preconditioning on MDA, Calcium Cytosol Concentration, and Mitochondrial Edema in Reperfusion Ischemia Injury: Research on Tetralogy Fallot Patients With Correction Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Indonesia University · Academic / Other
- Sex
- All
- Age
- 1 Year – 6 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclosporin | Cyclosporin was administered intravenously with the dose of 3 mg/ kg body weight |
| PROCEDURE | remote 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 |
| DRUG | Placebo | Intravenous placebo |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-12-01
- Completion
- 2022-09-01
- First posted
- 2023-01-20
- Last updated
- 2023-01-20
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT05691764. Inclusion in this directory is not an endorsement.