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Completed

NCT Number: NCT05691764

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

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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Key information

Conditions

Myocardial Injury Cardiac Surgery Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Tetralogy of Fallot Vascular Diseases

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indonesia University

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporin

Drug

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

Other names: Sandimmun

Remote ischemic preconditioning

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

Other names: RIPC

Placebo

Drug

Intravenous placebo

Primary outcomes

  1. Malondialdehyde (MDA)

    Time frame: 1 year

    ROS level is determined by measuring MDA concentration (nmol/mL)

  2. Calcium cytosol concentration

    Time frame: 1 year

    Calcium concentration (nmol/mL) in cytosol is determined by ratiometric analysis on Fura Red- dyed heart cells.

  3. Mitochondrial edema

    Time frame: 1 year

    Mitochondrial edema (%) is measured by decreasing of optical density that indicates change in mitochondrial matrix volume.

Secondary outcomes

  1. Cardiac index

    Time frame: 1 year

    Examined with echocardiography, unit of measurement is litres per minute per square metre (L/min/m2).

  2. Troponin I

    Time frame: 1 year

    Measured from venous blood, unit of measurement is nanograms per milliliter (ng/mL).

  3. Creatine kinase- MB (CKMB)

    Time frame: 1 year

    Measured from venous blood, unit of measurement is units per liter (IU/L).

  4. Vasoactive inotropic score (VIS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 20, 2023
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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