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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiopulmonary Bypass; AKI - Acute Kidney Injury
• Intervention / Treatment: Drug: Methylprednisolone group

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 saline as a placebo after the induction of anesthesia and before initiating CPB.
2. Methylprednisolone group / Interventional group receives a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.

Measurements:

Primary outcome:

Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.

Secondary outcome:

1. Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl) for 7 days,
2. Duration of ICU stay,
3. Length of hospital stay (LOS),
4. Incidence of wound infection,
5. Incidence of peptic ulcer,
6. Incidence of sepsis.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine; Phone Number: +201091541157; Email: abdelrahman.atef@med.asu.edu.eg

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 00202
      • Recruiting
      • Ain Shams University
      • Contact: Abdelrahman Atef Dr.Abdelrahman, M.B., B.Ch Faculty of Medicine; Phone Number: 01091541157; Email: abdelrahman.atef@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; (Placebo group / Control group) will receive normal saline as a placebo after the induction of anesthesia and before initiating CPB.
Active Comparator: Methylprednisolone group; (Methylprednisolone group ) receive a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of occurrence of postoperative acute kidney injury	Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.	7 days post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperatively hyperglycemia	1. Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl).	7 days post-operative
Duration of ICU stay,	Duration of ICU stay,	7 days post-operative
Length of hospital stay	Length of hospital stay	14 Day post-operative
Incidence of wound infection	Incidence of wound infection	7 days post-operative
Incidence of peptic ulcer	Monitoring attacks of hematemesis or melena	7 days post-operative
Incidence of sepsis	Incidence of sepsis.	7 days post-operative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: CPB; AKI
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Antineoplastic Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protective Agents; Neuroprotective Agents; Methylprednisolone Acetate; Prednisolone; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: MD47/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No