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NOT YET RECRUITING
NCT07668141
PHASE3

Colistin Nephrotoxicity and Role of Alpha Lipoic Acid

Sponsor: Helwan University

View on ClinicalTrials.gov

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.

Official title: Colistin Nephrotoxicity in Hospitalized Patients: The Role of Biomarkers in Guiding the Preventive Strategies

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2026-06-30

Completion Date

2027-02-28

Last Updated

2026-06-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

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.

Locations (2)

6th October Hospital-Dokki-General Authority for Health Insurance Organization

Giza, Egypt

Al-Haram Hospital

Giza, Egypt