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Recruiting Phase 1 NCT06917859

Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass

Trial Parameters

Condition Cardiopulmonary Bypass
Sponsor Ain Shams University
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 170
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-02-01
Completion 2026-02-01
Interventions
Methylprednisolone group

Brief Summary

The aim of the planned study is to assess the prophylactic effect of intraoperative administration of a single dose of methylprednisolone 2 (mg/kg) in decreasing the incidence of postoperative acute kidney injury after cardiac surgeries with cardiopulmonary bypass.

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 requiri

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