Colistin Nephrotoxicity and Role of Alpha Lipoic Acid

Starting soon · Phase 3

Conditions studied: Nephrotoxicity

In brief

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.

Key facts

Study ID

NCT07668141

Run by

Helwan University

People needed

88

Starts

2026-06-30

Expected to finish

2027-02-28

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 6th October Hospital-Dokki-General Authority for Health Insurance Organization — Giza, Egypt
• Al-Haram Hospital — Giza, Egypt

Full record on ClinicalTrials.gov

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