Colistin Nephrotoxicity and Role of Alpha Lipoic Acid (NCT07668141) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Colistin Nephrotoxicity and Role of Alpha Lipoic Acid
Egypt88 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in urinary kidney injury molecule-1 (KIM-1)