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Recruiting NCT06917859

Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass

Phase I Interventional Cardiopulmonary Bypass AKI - Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methylprednisolone group.
Who it may be relevant to
Registry conditions: Cardiopulmonary Bypass, AKI - Acute Kidney Injury. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Incidence of occurrence of postoperative acute kidney injury [Time frame: 7 days post-operative]
Secondary outcome measures (6)
  • Incidence of postoperatively hyperglycemia [Time frame: 7 days post-operative]
  • Duration of ICU stay, [Time frame: 7 days post-operative]
  • Length of hospital stay [Time frame: 14 Day post-operative]
  • Incidence of wound infection [Time frame: 7 days post-operative]
  • Incidence of peptic ulcer [Time frame: 7 days post-operative]
  • Incidence of sepsis [Time frame: 7 days post-operative]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Ain Shams University — Cairo

Identifiers

NCT: NCT06917859 · MD47/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗