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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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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

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Myocardial Injury Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Cyclosporin + RIPC

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.

Group Type EXPERIMENTAL

Cyclosporin

Intervention Type DRUG

Cyclosporin was administered intravenously with the dose of 3 mg/ kg body weight

remote ischemic preconditioning

Intervention Type PROCEDURE

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

Control

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravenous placebo

Interventions

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Cyclosporin

Cyclosporin was administered intravenously with the dose of 3 mg/ kg body weight

Intervention Type DRUG

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

Intervention Type PROCEDURE

Placebo

Intravenous placebo

Intervention Type DRUG

Other Intervention Names

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Sandimmun RIPC

Eligibility Criteria

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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.