RecruitingPhase 1NCT06917859

Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass

Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass: A Randomized Double-Blinded Clinical Study

Sponsor

Ain Shams University

Enrollment

170 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

AKI - Acute Kidney Injury Cardiopulmonary Bypass

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

Age 18-65 years.
Sex: Both sexes.
Patients with American Society of Anesthesiologists (ASA) score III-IV.
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 Criteria14

Declining to give written informed consent.
History of allergy to the medications used in the study.
Diabetic patients with HbA1C \>6.5
Moderate to severe hepatic diseases (Child B-C)
Hepatic dysfunction: INR \> 1.5, serum albumin \< 2.9 g%.
Renal dysfunction (serum Creatinine level \>1.3 mg/dl, or GFR \< 80 ml/min./1.73/m2
Patients with a recent history of AKI.
Patients undergoing urgent cardiac surgery.
Patients undergoing cardiac surgeries with deep hypothermic total circulatory arrest.
Planned off-pump procedure.
Any cardiac surgery exceeds 45 minutes on Aortic cross clamp.
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)
Delayed extubation for more than 6 hours postoperative.
Patients developed postoperative complications as (septic shock and bleeding)

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Interventions

DRUGMethylprednisolone group

In this study patients will be given a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.