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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.
Patients undergoing any type of elective cardiac surgical procedure requiring CPB will be randomly assigned into one of the following groups
Measurements:
Primary outcome:
Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.
Secondary outcome:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | (Placebo group / Control group) will receive normal saline as a placebo after the induction of anesthesia and before initiating CPB. | |
| Methylprednisolone group | Active Comparator | (Methylprednisolone group ) receive a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone group | Drug | In this study patients will be given a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of occurrence of postoperative acute kidney injury | Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria. | 7 days post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperatively hyperglycemia | 1. Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl). | 7 days post-operative |
| Duration of ICU stay, | Duration of ICU stay, |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine | Contact | +201091541157 | abdelrahman.atef@med.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | Abbasia | 00202 | Egypt |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 7 days post-operative |
| Length of hospital stay | Length of hospital stay | 14 Day post-operative |
| Incidence of wound infection | Incidence of wound infection | 7 days post-operative |
| Incidence of peptic ulcer | Monitoring attacks of hematemesis or melena | 7 days post-operative |
| Incidence of sepsis | Incidence of sepsis. | 7 days post-operative |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |