Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass

NCT06917859 | Recruiting Phase 1 DMC

• 1 other identifier: MD47/2025
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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 kidney injury after cardiac surgeries with cardiopulmonary bypass.

Conditions

Cardiopulmonary Bypass; AKI - Acute Kidney Injury

Keywords

AKI; CPB

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of postoperatively hyperglycemia

  7 days post-operative

• Duration of ICU stay,

  7 days post-operative

• Length of hospital stay

  14 Day post-operative

• Incidence of wound infection

  7 days post-operative

• Incidence of peptic ulcer

  7 days post-operative

Study Arms (2)

Control group

NO INTERVENTION

(Placebo group / Control group) will receive normal saline as a placebo after the induction of anesthesia and before initiating CPB.

Methylprednisolone group

ACTIVE COMPARATOR

(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

Interventions

Methylprednisolone group DRUG

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.

Methylprednisolone group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, 00202, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine

CONTACT

+201091541157; abdelrahman.atef@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: April 9, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-02

Locations

EG (1)