Using methylprednisolone to prevent kidney injury during heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ain Shams University
  Cairo, Abbasia, Egypt Recruiting

Study contacts

• Study coordinator: Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine
• Email: abdelrahman.atef@med.asu.edu.eg
• Phone: +201091541157

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Optimized Flow for Obese Patients Undergoing Heart Surgery

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• Integrated intraoperative hemodynamic monitoring during cardiac surgery with CPB

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• SP16 to help prevent kidney injury during cardiac surgery in people with CKD

  Researchers are testing SP16 to see if it can prevent acute kidney injury in adults with chronic kidney disease who are having heart surgery that uses a heart-lung machine.

  Recruiting Phase 2 University of Erlangen-Nürnberg Medical School · Erlangen, Bavaria · NCT07661940

• Preventive Narrative Exposure for PTSD After Cardiac Surgery in the ICU

  In adults having cardiopulmonary bypass heart surgery, this trial tests whether an ICU-based narrative exposure intervention helps prevent posttraumatic stress symptoms compared with standard care.

  Recruiting First Affiliated Hospital of Fujian Medical University · Fuzhou, Fujian · NCT07632131

• Impact of cardiopulmonary bypass on platelet lipids and bleeding after cardiac surgery

  This study tests how CPB changes platelet lipid metabolism and procoagulant platelets to see if these changes relate to inflammation and bleeding after cardiac surgery.

  Recruiting Université Catholique de Louvain · Brussels · NCT07630987

• Transcutaneous auricular vagus nerve stimulation to prevent kidney injury after heart surgery

  This trial tests whether applying a non-invasive ear stimulation (taVNS) around the time of elective heart surgery can help prevent acute kidney injury in adults undergoing cardiopulmonary bypass.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang · NCT07549243

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.