Comparing N-Acetylcysteine and Alpha-Lipoic Acid for Kidney Damage from Colistin
Evaluation of the Efficacy and Safety of N-Acetylcysteine Versus Alpha-Lipoic Acid on the Occurrence and Severity of Colistin-Induced Nephrotoxicity in Critically Ill Patients
This study is testing whether N-acetylcysteine or Alpha-lipoic acid can help protect the kidneys from damage caused by colistin in critically ill patients with tough bacterial infections.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06650384 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of N-acetylcysteine versus Alpha-lipoic acid in preventing kidney damage caused by colistin in critically ill patients with multi-drug-resistant Gram-negative bacterial infections. The study involves administering either N-acetylcysteine or Alpha-lipoic acid alongside colistin treatment to assess their protective effects on renal function. Patients will be monitored for signs of acute kidney injury during the treatment period. The trial aims to provide insights into safer treatment options for infections that are difficult to manage due to antibiotic resistance.
Who should consider this trial
Good fit: Ideal candidates are critically ill adults aged 18 and older who are starting colistin treatment for suspected or confirmed multi-drug-resistant Gram-negative infections.
Not a fit: Patients with existing acute kidney injury or other significant kidney disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney protection for patients receiving colistin, enhancing treatment outcomes for severe infections.
How similar studies have performed: While the use of N-acetylcysteine for nephroprotection has been explored in other contexts, this specific comparison with Alpha-lipoic acid in the setting of colistin-induced nephrotoxicity is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients ≥ 18 years 2. Critically ill patients initiating treatment with colistin for suspected or confirmed multi-drug-resistant Gram-negative bacterial infection as per culture Exclusion Criteria: 1. Patient is in AKI according to KDIGO guidelines in 2012 KDIGO.org. Accessed at 17/2/2024) 2. Any kidney disorder including (glomerulonephritis, polycystic kidney disease, kidney stones, interstitial nephritis, renal artery stenosis and renal carcinoma). 3. Known allergy to colistin, N-acetylcysteine or alpha-lipoic acid 4. Patients with factors requiring NPO (nothing per oral)
Where this trial is running
Cairo
- Critical Care Medicine Department,Cairo University Hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Dina H El Adly, MSc — Critical Care Medicine Department, Cairo University Hospitals, Cairo, Egypt
- Study coordinator: Dina H El Adly, MSc
- Email: dina_hussein1983@yahoo.com
- Phone: +201121717315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.