Clinical trial NCT06917859: Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
Official title: Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass: A Randomized Double-Blinded Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cardiopulmonary Bypass
AKI - Acute Kidney Injury
Keywords: AKI
CPB
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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)

Primary outcomes:
measure: Incidence of occurrence of postoperative acute kidney injury
timeFrame: 7 days post-operative
Secondary outcomes:
measure: Incidence of postoperatively hyperglycemia
timeFrame: 7 days post-operative
measure: Duration of ICU stay,
timeFrame: 7 days post-operative
measure: Length of hospital stay
timeFrame: 14 Day post-operative
measure: Incidence of wound infection
timeFrame: 7 days post-operative
measure: Incidence of peptic ulcer
timeFrame: 7 days post-operative
measure: Incidence of sepsis
timeFrame: 7 days post-operative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbasia
Study officials:
References: