Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06917859

Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ain Shams University

Cairo, Abbasia, 00202, Egypt

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

01091541157

About this study

Patients undergoing any type of elective cardiac surgical procedure requiring CPB will be randomly assigned into one of the following groups

  • Placebo group / Control group will receives normal saline as a placebo after the induction of anesthesia and before initiating CPB.
  • 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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Incidence of occurrence of postoperative acute kidney injury

    Time frame: 7 days post-operative

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

Secondary outcomes

  1. Incidence of postoperatively hyperglycemia

    Time frame: 7 days post-operative

    • Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl).
  2. Duration of ICU stay,

    Time frame: 7 days post-operative

    Duration of ICU stay,

  3. Length of hospital stay

    Time frame: 14 Day post-operative

    Length of hospital stay

  4. Incidence of wound infection

    Time frame: 7 days post-operative

    Incidence of wound infection

  5. Incidence of peptic ulcer

    Time frame: 7 days post-operative

    Monitoring attacks of hematemesis or melena

  6. Incidence of sepsis

    Time frame: 7 days post-operative

    Incidence of sepsis.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+201091541157

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.