Actively Recruiting
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass: A Randomized Double-Blinded Clinical Study
Led by Ain Shams University · Updated on 2025-04-09
170
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether giving a single dose of methylprednisolone during cardiac surgery can reduce the risk of acute kidney injury after the operation. The study focuses on patients undergoing elective heart surgeries that require cardiopulmonary bypass. This research aims to understand if methylprednisolone can protect kidney function in this setting while monitoring other health outcomes. Participants will be randomly assigned to one of two groups: one group will receive a single intravenous dose of methylprednisolone (2 mg/kg) after anesthesia is started and before cardiopulmonary bypass begins, while the other group will receive a placebo of normal saline at the same time. This is a double-blinded study, so neither the patients nor the researchers will know which treatment is given during the trial. During the study, participants will be closely monitored for seven days after surgery to assess the occurrence of acute kidney injury using specific criteria. Researchers will also track secondary outcomes like high blood sugar, length of ICU and hospital stays, wound infections, peptic ulcers, and sepsis. The total hospital stay is monitored up to 14 days post-surgery. Safety and recovery will be carefully evaluated throughout the trial period.
CONDITIONS
Brief Title
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years
- Both sexes are eligible
- Patients with American Society of Anesthesiologists (ASA) score III-IV
- Scheduled for any elective cardiac surgery requiring cardiopulmonary bypass (e.g., CABG, valve repair/replacement, or combined procedures)
You will not qualify if you...
- Declining to give written informed consent
- Allergy to study medications
- Diabetes with HbA1C greater than 6.5
- Moderate to severe liver disease (Child B-C)
- Liver dysfunction with INR greater than 1.5 or serum albumin less than 2.9 g%
- Kidney dysfunction with serum creatinine over 1.3 mg/dl or GFR less than 80 ml/min/1.73m2
- Recent history of acute kidney injury
- Urgent cardiac surgery
- Cardiac surgery with deep hypothermic total circulatory arrest
- Planned off-pump cardiac procedure
- Cardiac surgery exceeding 45 minutes of aortic cross clamp time
- Need for high doses of inotropes or vasopressors during or after surgery
- Delayed extubation over 6 hours postoperatively
- Postoperative complications such as septic shock or bleeding
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day
Participants receive a single intravenous dose of methylprednisolone or placebo after anesthesia induction and before the start of cardiopulmonary bypass during elective cardiac surgery.
1 surgery day visit
Duration - 7 to 14 days post-operative
Participants are monitored for postoperative outcomes including kidney function, blood glucose levels, ICU stay, wound infection, peptic ulcer, and sepsis.
Daily assessments for up to 7 days and hospital stay monitoring up to 14 days
Trial Site Locations
Total: 1 location
1
Ain Shams University
Cairo, Abbasia, Egypt, 00202
Actively Recruiting
Research Team
A
Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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