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Efficacy and Safety of N-Acetylcysteine Versus Alpha-Lipoic Acid in Colistin-Induced Nephrotoxicity

NCT06650384 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-02-17

No results posted yet for this study

Summary

Healthcare- associated infections that caused by multi-drug-resistant Gram-negative bacteria (MDR G-ve) represent the most important problem that face the critically ill patients in the ICU. The available broad-spectrum antibiotics as penicillin, fluoroquinolones, aminoglycosides, and β-lactams fail to overcome these aggressive organisms. Accordingly, this led to the reconsideration of old drugs such as polymyxin B and polymyxin E (also known as colistin) that were previously considered to be too toxic for clinical use in the treatment of MDR G-ve bacteria. Colistin can be used as monotherapy or in combination with other antibiotics as high dose tigecycline, carbapenem or high-dose ampicillin/sulbactam.

Colistin associated acute kidney injury (CA-AKI) is the frequently observed side effect in ICU patients treated with colistin that may lead to cessation of treatment. Accordingly, it is important to monitor renal functions prior to and during colistin treatment to detect the early signs of renal injury and minimize long term renal dysfunction.

Inflammation with release of reactive oxygen species (ROS) can lead to renal tubular cells apoptosis. Several animal studies proved the beneficial effect of the concomitant use of antioxidants as N-acetylcysteine, alpha lipoic acid in preventing or attenuating colistin induced nephrotoxicity by their potent antioxidant effects Therefore, a clinical trial will be carried out to evaluate the efficacy and safety of N-acetylcysteine versus Alpha-lipoic acid in the prevention of colistin-induced nephrotoxicity in critically ill patients.

Conditions

  • Nephrotoxicity

Interventions

DRUG

Addition of sachets of N-acetyl cysteine 1200 mg twice/day to the maintenance dose of colistin

Group2 (n=60): (IV) colistin 300mg CBA loading dose then maintenance dose of 150-180 mg CBA twice daily based on Crcl calculated using Cockcroft -Gault equation in addition to enteral sachets of N-acetyl cysteine 1200 mg twice /day

DRUG

Addition of Alpha-lipoic acid 600mg twice daily to the maintenance dose of colistin

Group3 (n=60): (IV) colistin 300mg CBA loading dose then maintenance dose 150-180 mg CBA twice daily based on Crcl calculated using Cockcroft -Gault equation in addition to enteral Alpha-lipoic acid 600mg twice/day

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Dina H El Adly, MSc · Critical Care Medicine Department, Cairo University Hospitals, Cairo, Egypt

  • Lamia M El Wakeel, PhD · Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University,Cairo, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-01-01
Completion
2026-02-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650384 on ClinicalTrials.gov