The Effect of Curcumin Against Colistin-induced Nephrotoxicity

Acute Kidney Injury Clinical Trial

Official title:

The Effect of Curcumin Against Colistin-induced Nephrotoxicity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05613361
• Other study ID #: curcumin in nephrotoxicity
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: October 2023
• Source: October 6 University
• Contact: Alaa M. Hammad
• Phone: 01000675555
• Email: alaa.hammad.ph[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: October 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Drug-Induced Nephropathy

Intervention

Drug:
• Colistin
added for infection with multi drug resistant bacteria
• Curcumin
added for the possible nephroprotective effect

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
October 6 University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of acute kidney injury	colistin induced nephrotoxicity (CIN) is defined as increase of serum creatinine by 0.3 mg/dL 48 hours after colistin administration	Baseline to hospital discharge, an average of 14 days.
Secondary	The incidence of acute tubular necrosis (ATN)	will be evaluated by fractional excreted sodium (FENa)	Baseline to hospital discharge, an average of 14 days.
Secondary	The difference between the levels of urinary NGAL		Baseline to hospital discharge, an average of 14 days.
Secondary	Mortality rate		Baseline to 30 days post discharge
Secondary	Total length of ICU and hospital stays.		Baseline to hospital discharge, an average of 14 days.