Using methylprednisolone to prevent kidney injury during heart surgery

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

This study is testing if giving a single dose of methylprednisolone during heart surgery can help prevent kidney injury after the operation.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ain Shams University (Academic / other)
• Locations: 1 site (Cairo, Abbasia)
• Trial ID: NCT06917859 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a single dose of methylprednisolone administered during cardiac surgeries that require cardiopulmonary bypass (CPB) in reducing the incidence of postoperative acute kidney injury (AKI). Patients will be randomly assigned to receive either methylprednisolone or a placebo after anesthesia induction and before CPB initiation. The primary outcome will be the occurrence of AKI within seven days post-surgery, assessed using the RIFLE criteria, while secondary outcomes will include hyperglycemia, ICU stay duration, hospital length of stay, and other postoperative complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 scheduled for elective cardiac surgeries requiring cardiopulmonary bypass with an ASA score of III-IV.

Not a fit: Patients with a history of renal dysfunction, severe hepatic diseases, or those undergoing urgent surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of acute kidney injury in patients undergoing cardiac surgery, leading to better postoperative outcomes.

How similar studies have performed: While the use of corticosteroids in surgical settings has been explored, this specific prophylactic approach for renal protection during cardiac surgeries is relatively novel.

Eligibility criteria

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)

Where this trial is running

Cairo, Abbasia

• Ain Shams University — Cairo, Abbasia, Egypt (Recruiting)

Study contacts

• Study coordinator: Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine

Conditions Cardiopulmonary Bypass; AKI - Acute Kidney Injury; AKI; CPB