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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

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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