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

NCT05691764 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-01-20

No results posted yet for this study

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.

Conditions

  • Myocardial Injury
  • Cardiac Surgery

Interventions

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

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Jefferson K Hidayat, MD · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-12-01
Completion
2022-09-01

Countries

  • Indonesia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691764 on ClinicalTrials.gov