NCT06917859

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cardiopulmonary Bypass
• AKI - Acute Kidney Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-02-01
• Completion: 2026-12-01
• First posted: 2025-04-09
• Last updated: 2025-04-09

Locations

1 site across 1 country: Egypt