The Effect of Curcumin Against Colistin-induced Nephrotoxicity
Phase 3
Recruiting
- Conditions
- Acute Kidney InjuryDrug-Induced Nephropathy
- Interventions
- Registration Number
- NCT05613361
- Lead Sponsor
- October 6 University
- Brief Summary
The goal of this study is to investigate the possible nephroprotective effect of curcumin in critically ill patients receiving colistin.
- Detailed Description
The study will investigate the possible nephroprotective effect of curcumin when added to patients infected by MDR Gram-negative bacteria and require intravenous colistin therapy, curcumin will be given concurrently with colistin and discontinued at the same time as Colistin.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 214
Inclusion Criteria
- All critically ill adult patients (18-65 years old) who are infected by MDR Gram-negative bacteria and require intravenous colistin therapy
Exclusion 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Colistin patients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours. Group 2 Colistin patients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours and curcumin will be administered as orally or through nasogastric tube at a dose of 2 capsules every 6 hours (1 gm/6 hour) Group 2 Curcumin patients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours and curcumin will be administered as orally or through nasogastric tube at a dose of 2 capsules every 6 hours (1 gm/6 hour)
- Primary Outcome Measures
Name Time Method The incidence of acute kidney injury Baseline to hospital discharge, an average of 14 days. colistin induced nephrotoxicity (CIN) is defined as increase of serum creatinine by 0.3 mg/dL 48 hours after colistin administration
- Secondary Outcome Measures
Name Time Method Mortality rate Baseline to 30 days post discharge The incidence of acute tubular necrosis (ATN) Baseline to hospital discharge, an average of 14 days. will be evaluated by fractional excreted sodium (FENa)
The difference between the levels of urinary NGAL Baseline to hospital discharge, an average of 14 days. Total length of ICU and hospital stays. Baseline to hospital discharge, an average of 14 days.
Trial Locations
- Locations (1)
Cairo University Hospitals
🇪🇬Cairo, Egypt