The Effect of Curcumin Against Colistin-induced Nephrotoxicity

October 6 University

Status and phase: Enrolling; Phase 3

Conditions: Acute Kidney Injury; Drug-Induced Nephropathy

Treatments: Drug: Curcumin; Drug: Colistin

Study type: Interventional

Funder types: Other

Identifiers

NCT05613361

curcumin in nephrotoxicity

Details and patient eligibility

About

The goal of this study is to investigate the possible nephroprotective effect of curcumin in critically ill patients receiving colistin.

Full 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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Drug: Colistin

Group 2

Active Comparator group

Description:

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)

Treatment:

Drug: Curcumin

Drug: Colistin