The Effect of Curcumin Against Colistin-induced Nephrotoxicity

• Sponsor: October 6 University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05613361
• Collaborator: Cairo University (Other)
• Enrollment: 214
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 9.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury; Drug-Induced Nephropathy	Drug: Colistin; Drug: Curcumin	Phase 3

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 214 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effect of Curcumin Against Colistin-induced Nephrotoxicity
• Actual Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Mar 30, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 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.	Drug: Colistin; added for infection with multi drug resistant bacteria
Active Comparator: Group 2 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)	Drug: Colistin; added for infection with multi drug resistant bacteria; Drug: Curcumin; added for the possible nephroprotective effect

Outcome Measures

Primary Outcome Measures

1. 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

1. The incidence of acute tubular necrosis (ATN) [Baseline to hospital discharge, an average of 14 days.]

   will be evaluated by fractional excreted sodium (FENa)

2. The difference between the levels of urinary NGAL [Baseline to hospital discharge, an average of 14 days.]

3. Mortality rate [Baseline to 30 days post discharge]

4. Total length of ICU and hospital stays. [Baseline to hospital discharge, an average of 14 days.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University Hospitals	Cairo		Egypt	1133

Sponsors and Collaborators

• October 6 University
• Cairo University

Investigators

• Principal Investigator: Nirmeen A. Sabry, Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University
• Principal Investigator: Maggie M. Abbassi, Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University
• Principal Investigator: Rania El-Husseiny, Professor of Critical Care Medicine, Faculty of Medicine Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Mohammed Hammad, Principal Investigator, October 6 University
• ClinicalTrials.gov Identifier: NCT05613361
• Other Study ID Numbers: curcumin in nephrotoxicity
• First Posted: Nov 14, 2022
• Last Update Posted: Nov 15, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acute Kidney Injury; Colistin; Curcumin

Study Results

No Results Posted as of Nov 15, 2022