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New treatment option for Cardiopulmonary Bypass
Official title Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
ClinicalTrials.gov ID: NCT06917859
What this study is testing
What is Methylprednisolone group?
Methylprednisolone group is an investigational medicine, being studied as a potential treatment for cardiopulmonary bypass.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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 (
- 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...
- Delayed extubation for more than 6 hours postoperative.
- Patients developed postoperative complications as (septic shock and bleeding)
The study team makes the final eligibility decision.
Where it's taking place
- Cairo, Abbasia, Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cairo, Abbasia, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.