Status:
RECRUITING
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
Lead Sponsor:
Ain Shams University
Conditions:
Cardiopulmonary Bypass
AKI - Acute Kidney Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 k...
Detailed Description
Patients undergoing any type of elective cardiac surgical procedure requiring CPB will be randomly assigned into one of the following groups 1. Placebo group / Control group will receives normal sali...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06917859
Start Date
February 1 2025
End Date
December 1 2026
Last Update
April 9 2025
Active Locations (1)
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1
Ain Shams University
Cairo, Abbasia, Egypt, 00202