Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-29 @ 12:15 AM
Study NCT ID:
NCT06917859
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass: A Randomized Double-Blinded Clinical Study
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: