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Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
RECRUITINGPhase 1Sponsored by Ain Shams University
Actively Recruiting
PhasePhase 1
SponsorAin Shams University
Started2025-02-01
Est. completion2026-02-01
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06917859
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
Age: 18 Years – 65 YearsHealthy volunteers accepted
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)
Conditions3
AKI - Acute Kidney InjuryCardiopulmonary BypassHeart Disease
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Actively Recruiting
PhasePhase 1
SponsorAin Shams University
Started2025-02-01
Est. completion2026-02-01
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06917859