Colistin Nephrotoxicity and Role of Alpha Lipoic Acid

NCT07668141 · tracked via the Priya Life Science Egypt tracker

Sponsor

Helwan University

Phase

Phase 3

Started

2026-06-30

Last updated

2026-06-25

Condition(s) studied

Nephrotoxicity

Investigational drug(s) / intervention(s)

alpha lipoic acid drug (thioctic acid acid)

alpha lipoic acid drug (thioctic acid acid): Oral alpha-lipoic acid will be administered at the start of colistin therapy till the end of the colistin course by a dose of 600 mg every 8 hours to be taken 30 min before meals in the intervention group.

Study summary

Nephrotoxicity is a great concern in patients receiving intravenous colistin and there is a disparity in the reported rates between previous studies. Several preclinical researches studied the effect of the antioxidants (e.g. L.carnitine, vitamin C, vitamin E, N-acetyl cysteine, and alpha lipoic acid) in reducing the risk of colistin-induced nephrotoxicity but there is a lack of clinical studies on human. Due to the paucity of studies that early predict colistin-induced nephrotoxicity using early acute kidney injury "AKI" biomarkers e.g. kidney injury molecule 1"KIM1" and the lack of human studies that evaluate the role of alpha lipoic acid in ameliorating colistin-induced nephrotoxicity, so this study will be conducted.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Adult patients who receive intravenous colistin and had positive cultures of multidrug resistant gram negative bacteria. * Patients who receive colistin for at least 3 days during their treatment. Exclusion Criteria: * Patients who receive inhaled colistin. * Patients who had AKI at baseline * chronic kidney disease patients on regular hemodialysis. * Renal transplant patients * Concurrent use of other nephrotoxic drugs e.g. vancomycin, gentamicin, amikacin and amphotericin B. * Concurrent use of other antioxidants e.g. vitamin C, vitamin E and N-acetyl cysteine. * Patients are not willing to participate in the study. * Patients with any missed doses of colistin and or alpha-lipoic acid. * Patients with incomplete medical data * Pregnant or breastfeeding women.

Primary outcome measure(s)

Change in urinary kidney injury molecule-1 (KIM-1) — Baseline to Day 5
Urinary KIM-1 will be measured at baseline and on Day 5 of treatment in patients receiving colistin alone or colistin plus alpha-lipoic acid.

Trial sites (2)

Facility	City	Region	Status
6th October Hospital-Dokki-General Authority for Health Insurance Organization	Giza	Egypt
Al-Haram Hospital	Giza	Egypt

More Helwan University trials in Egypt

Cardiotoxicity in Breast Cancer Patients Recruiting

Using Retrograde Intrarenal Surgery for Managing Staghorn Renal Stones. Recruiting

Comparative Efficacy and Safety of Propofol-Ketamine Combination Versus Propofol Monotherapy in Geriatric Patients Under Invasive Ventilation Recruiting

New Method to Close Nasal Septal Perforation Recruiting

A Direct Head-to-head Comparison of Ustekinumab With Infliximab for the Treatment of Ulcerative Colitis Active, not recruiting

Other trials for the same condition

Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity Recruiting

Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity Starting soon

L-Carnitine Protective Effect in Nephrotoxicity Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07668141 on ClinicalTrials.gov ↗ ← All trials in Egypt