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The Effect of Curcumin Against Colistin-induced Nephrotoxicity

Primary Purpose

Acute Kidney Injury, Drug-Induced Nephropathy

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Colistin
Curcumin
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cairo University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm 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.

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The incidence of acute tubular necrosis (ATN)
will be evaluated by fractional excreted sodium (FENa)
The difference between the levels of urinary NGAL
Mortality rate
Total length of ICU and hospital stays.

Full Information

First Posted
November 1, 2022
Last Updated
November 10, 2022
Sponsor
October 6 University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05613361
Brief Title
The Effect of Curcumin Against Colistin-induced Nephrotoxicity
Official Title
The Effect of Curcumin Against Colistin-induced Nephrotoxicity
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Drug-Induced Nephropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm 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.
Arm Title
Group 2
Arm Type
Active Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Colistin
Intervention Description
added for infection with multi drug resistant bacteria
Intervention Type
Drug
Intervention Name(s)
Curcumin
Intervention Description
added for the possible nephroprotective effect
Primary Outcome Measure Information:
Title
The incidence of acute kidney injury
Description
colistin induced nephrotoxicity (CIN) is defined as increase of serum creatinine by 0.3 mg/dL 48 hours after colistin administration
Time Frame
Baseline to hospital discharge, an average of 14 days.
Secondary Outcome Measure Information:
Title
The incidence of acute tubular necrosis (ATN)
Description
will be evaluated by fractional excreted sodium (FENa)
Time Frame
Baseline to hospital discharge, an average of 14 days.
Title
The difference between the levels of urinary NGAL
Time Frame
Baseline to hospital discharge, an average of 14 days.
Title
Mortality rate
Time Frame
Baseline to 30 days post discharge
Title
Total length of ICU and hospital stays.
Time Frame
Baseline to hospital discharge, an average of 14 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa M. Hammad
Phone
01000675555
Email
alaa.hammad.ph@o6u.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirmeen A. Sabry
Organizational Affiliation
Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maggie M. Abbassi
Organizational Affiliation
Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rania El-Husseiny
Organizational Affiliation
Professor of Critical Care Medicine, Faculty of Medicine Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University Hospitals
City
Cairo
ZIP/Postal Code
1133
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa M Hammad
Phone
01000675555
Email
alaa.hammad.ph@o6u.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Effect of Curcumin Against Colistin-induced Nephrotoxicity

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