Colistin Nephrotoxicity and Role of Alpha Lipoic Acid

ConditionNephrotoxicity

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-80

SponsorHelwan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who receive inhaled colistin.

Patients who had AKI at baseline

chronic kidney disease patients on regular hemodialysis.

Renal transplant patients

Trial design

Design model

Parallel

Treatments tested in this trial

alpha lipoic acid drug (thioctic acid acid)
Drug
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.

Treatment groups

88 Participants

are divided into 2 treatment groups

Group A: Control groupNo intervention 0 interventions

Group B: alpha lipoic acid groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in urinary kidney injury molecule-1 (KIM-1)

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.

Time frame

Baseline to Day 5

Secondary outcomes

Time to Development of Acute Kidney Injury

Time from randomization to the first documented occurrence of acute kidney injury during colistin therapy in the control group and the intervention group.

Time frame

From randomization until the first occurrence of acute kidney injury, hospital discharge, death from any cause, or colistin discontinuation, whichever occurs first, assessed up to 30 days.

Sponsors and contacts

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Helwan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: