The Effect of Curcumin Against Colistin-induced Nephrotoxicity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Curcuminoids and Contrast-induced Acute Kidney Injury

NCT04890704

Acute Kidney Injury Contrast Media Toxicity Curcuminoid +1 more

COMPLETED EARLY_PHASE1

Coenzyme Q10 Role in Prevention of Contrast Induced Nephropathy in Acute Coronary Syndrome Patients.

NCT06429345

Contrast-induced Nephropathy

RECRUITING PHASE4

Drug Nephrotoxicity Amelioration by N-acetylcysteine

NCT06122311

Drug-Induced Nephropathy

COMPLETED NA

Efficacy and Safety of N-Acetylcysteine Versus Alpha-Lipoic Acid in Colistin-Induced Nephrotoxicity

NCT06650384

Nephrotoxicity

RECRUITING PHASE2/PHASE3

Ameliorating Contrast Induced Nephropathy After Coronary Angiography

NCT06139952

Coronary Artery Disease Nephropathy; Toxic, Drugs

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury Drug-Induced Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Colistin

Intervention Type DRUG

added for infection with multi drug resistant bacteria

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)

Group Type ACTIVE_COMPARATOR

Colistin

Intervention Type DRUG

added for infection with multi drug resistant bacteria

Curcumin

Intervention Type DRUG

added for the possible nephroprotective effect

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colistin

added for infection with multi drug resistant bacteria

Intervention Type DRUG

Curcumin

added for the possible nephroprotective effect

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No