Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery

University of Indonesia (UI)

Status: Completed

Conditions: Cardiac Surgery; Myocardial Injury

Treatments: Drug: Placebo; Drug: Cyclosporin; Procedure: remote ischemic preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05691764

IndonesiaUAnes055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Cyclosporin + RIPC

Experimental group

Description:

This group received cyclosporin intravenously 2 hours pre-induction of anesthesia, with the dose of 3 mg/ kg body weight. 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.

Treatment:

Procedure: remote ischemic preconditioning

Drug: Cyclosporin

Control

Placebo Comparator group

Description:

This group received placebo intravenously 2 hours pre-induction of anesthesia.

Treatment:

Drug: Placebo