Clinical Trials in Egypt / NCT06917859
Recruiting
Phase 1
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
NCT06917859 · tracked via the Priya Life Science Egypt tracker
Condition(s) studied
Cardiopulmonary BypassAKI - Acute Kidney Injury
Investigational drug(s) / intervention(s)
Methylprednisolone group
Methylprednisolone 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.
Study 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
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)
Primary outcome measure(s)
- Incidence of occurrence of postoperative acute kidney injury — 7 days post-operative
Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ain Shams University | Cairo | Abbasia | Recruiting |
More Ain Shams University trials in Egypt
3D Analysis of Soft Tissue Healing After Immediate Implant Placement Using PRF Vs HAM
Active, not recruiting
Association Between Plasma D Dimer in Adult CAP and Severity of Inflammatory Response and Survival
Recruiting
Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06917859 on ClinicalTrials.gov ↗ ← All trials in Egypt