The Effect of Curcumin Against Colistin-induced Nephrotoxicity

NCT05613361 | Unknown Phase 3

• 1 other identifier: curcumin in nephrotoxicity
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Kidney Injury; Drug-Induced Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The incidence of acute tubular necrosis (ATN)

  Baseline to hospital discharge, an average of 14 days.

• The difference between the levels of urinary NGAL

  Baseline to hospital discharge, an average of 14 days.

• Mortality rate

  Baseline to 30 days post discharge

• Total length of ICU and hospital stays.

  Baseline to hospital discharge, an average of 14 days.

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

ACTIVE COMPARATOR

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; Drug: Curcumin

Interventions

Colistin DRUG

added for infection with multi drug resistant bacteria

Group 1; Group 2

Curcumin DRUG

added for the possible nephroprotective effect

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All critically ill adult patients (18-65 years old) who are infected by MDR Gram-negative bacteria and require intravenous colistin therapy

You may not qualify if:

• 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.

Sponsors & Collaborators

• October 6 University: lead
• Cairo University: collaborator

Study Sites (1)

Cairo University Hospitals

Cairo, 1133, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Colistin; Curcumin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa M. Hammad

CONTACT

01000675555; alaa.hammad.ph@o6u.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 14, 2022
• Study Start: January 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: October 30, 2024
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)