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Recruiting
NCT05613361
The Effect of Curcumin Against Colistin-induced Nephrotoxicity
Conditions: Acute Kidney Injury, Drug-Induced Nephropathy
Sex: All
Ages: 18 Years – 65 Years
Phase: PHASE3
Enrollment: 214
Sponsor: October 6 University
Location: Egypt
Summary
The goal of this study is to investigate the possible nephroprotective effect of curcumin in critically ill patients receiving colistin.
Eligibility Criteria
Inclusion Criteria:All critically ill adult patients (18-65 years old) who are infected by MDR Gram-negative bacteria and require intravenous colistin therapyExclusion Criteria:Patients receiving intravenous colistin therapy for < 72 hours.Patients receiving renal replacement therapy (RRT).Patients with diseases that may contribute to renal impairment such as systemic lupus erythematosus, acute myocardial infarction, cancer, HIV infection, glucose-6-phosphate-dehydrogenase deficiency, or urinary tract stone.Pregnancy or breastfeeding.Known allergy to the study medications.Patients with chronic kidney diseases (creatinine clearance < 60 mg/dL).Elevated total liver enzymes (AST, and ALT) three times above the upper limit of normal.Patients with acute decompensated heart failure signs and symptoms requiring intravenous loop diuretics and/or intravenous inotropes and/or ACE inhibitors.Uncontrolled diabetes (Glycosylated hemoglobin (Hb A1C) >8%).Hypotensive patients defined as decrease in blood pressure less than 90/60 mm Hg.Recent use of vitamins with antioxidant properties such as beta carotene, vitamin E, vitamin C, selenium, or N-acetylcysteine or any other medications known to have nephroprotective activities.Patients receiving other nephrotoxic drugs at enrollment (e.g., aminoglycosides, vancomycin, or amphotericin B) or administration of contrast medium within 7 days.
Source: ClinicalTrials.gov (NCT05613361). StuddyBuddy aggregates publicly available trial information.