Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass

Launched by AIN SHAMS UNIVERSITY · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a single dose of a medication called methylprednisolone, given during heart surgery, can help protect the kidneys from damage that sometimes occurs after surgery, especially in patients who require heart-lung machines (also known as cardiopulmonary bypass). The researchers want to see if this medication can reduce the chances of developing acute kidney injury (AKI) after these surgeries.

To be eligible for this trial, participants need to be between 18 and 65 years old and scheduled for certain types of planned heart surgeries that involve the heart-lung machine. However, there are some important criteria that may exclude individuals, such as having certain allergies, diabetes with high blood sugar levels, or existing kidney or liver problems. If you join the trial, you will receive the study medication during your surgery and be monitored afterward to see how well your kidneys function. This study is currently looking for volunteers, so if you have questions or think you might qualify, it’s a good idea to talk to your doctor.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-65 years.
• • 2. Sex: Both sexes.
• • 3. Patients with American Society of Anesthesiologists (ASA) score III-IV.
• • 4. Patients scheduled for any kind of elective cardiac surgical procedure requiring cardiopulmonary bypass (e.g., coronary artery bypass grafting (CABG), valve repair/replacement, or combined procedures (
• Exclusion Criteria:
• • 1. Declining to give written informed consent.
• • 2. History of allergy to the medications used in the study.
• • 3. Diabetic patients with HbA1C \>6.5
• • 4. Moderate to severe hepatic diseases (Child B-C)
• • 5. Hepatic dysfunction: INR \> 1.5, serum albumin \< 2.9 g%.
• • 6. Renal dysfunction (serum Creatinine level \>1.3 mg/dl, or GFR \< 80 ml/min./1.73/m2
• • 7. Patients with a recent history of AKI.
• • 8. Patients undergoing urgent cardiac surgery.
• • 9. Patients undergoing cardiac surgeries with deep hypothermic total circulatory arrest.
• • 10. Planned off-pump procedure.
• • 11. Any cardiac surgery exceeds 45 minutes on Aortic cross clamp.
• • 12. Patients requiring high doses of inotropes and/or vasopressors intraoperative or postoperative (high-dose dopamine is defined as peak doses of \>15 μg/kg/min, high-dose norepinephrine is defined as peak dose \>0.1 μg/kg/min, high-dose epinephrine is defined as peak dose \>0.1 μg/kg/min)
• • 13. Delayed extubation for more than 6 hours postoperative.
• • 14. Patients developed postoperative complications as (septic shock and bleeding)