Clinical trial NCT05613361: The Effect of Curcumin Against Colistin-induced Nephrotoxicity
Official title: The Effect of Curcumin Against Colistin-induced Nephrotoxicity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Kidney Injury
Drug-Induced Nephropathy
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2022-11-14
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: The incidence of acute kidney injury
timeFrame: Baseline to hospital discharge, an average of 14 days.
Secondary outcomes:
measure: The incidence of acute tubular necrosis (ATN)
timeFrame: Baseline to hospital discharge, an average of 14 days.
measure: The difference between the levels of urinary NGAL
timeFrame: Baseline to hospital discharge, an average of 14 days.
measure: Mortality rate
timeFrame: Baseline to 30 days post discharge
measure: Total length of ICU and hospital stays.
timeFrame: Baseline to hospital discharge, an average of 14 days.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University
name: Nirmeen A. Sabry
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University
name: Maggie M. Abbassi
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Critical Care Medicine, Faculty of Medicine Cairo University
name: Rania El-Husseiny
role: PRINCIPAL_INVESTIGATOR
References: