Curcumin's effect on kidney damage from colistin
The Effect of Curcumin Against Colistin-induced Nephrotoxicity
This study is testing if curcumin can help protect the kidneys of critically ill patients receiving colistin for serious infections.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | October 6 University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05613361 on ClinicalTrials.gov |
What this trial studies
This study investigates the potential protective effects of curcumin on kidney function in critically ill patients who are receiving intravenous colistin therapy for infections caused by multidrug-resistant Gram-negative bacteria. Participants will receive curcumin alongside colistin, with both treatments being administered concurrently and discontinued simultaneously. The aim is to determine if curcumin can mitigate the nephrotoxic effects associated with colistin use in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are critically ill adults aged 18-65 who are infected with multidrug-resistant Gram-negative bacteria and require intravenous colistin therapy.
Not a fit: Patients who may not benefit include those with chronic kidney diseases, significant liver enzyme elevations, or other serious comorbidities that could affect renal function.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to protect kidney function in patients undergoing treatment with colistin.
How similar studies have performed: While the nephroprotective effects of curcumin have been explored in other contexts, this specific approach in critically ill patients receiving colistin is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- Cairo University Hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Nirmeen A. Sabry — Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University
- Study coordinator: Alaa M. Hammad
- Email: alaa.hammad.ph@o6u.edu.eg
- Phone: 01000675555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.