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Enrolling By Invitation NCT07873372

Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.

Conditions: Nephrotoxicity, Acute Kidney Injuries

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 120
Sponsor: Ain Shams University

Location: Ain Shams University Hospitals Cairo Cairo Governorate

Summary

Background: Vancomycin, a key antibiotic for MRSA infections, frequently causes nephrotoxicity (kidney damage) via oxidative stress, especially at the higher doses and longer durations now recommended. Antioxidants like rutin and ascorbic acid (vitamin C) have shown promise in reducing this toxicity in preclinical and limited human studies, but no trial has tested them together. Aim: Evaluate whether combined rutin + ascorbic acid supplementation reduces the incidence of vancomycin-induced nephrotoxicity (VAN) in adult patients, compared to ascorbic acid alone and a control group. Design: Prospective, open-label, randomized controlled, three-arm clinical trial; 120 adult patients recruited from Internal Medicine departments at Ain Shams University Hospital. Population: Adults (≥18) receiving vancomycin for ≥7 days for MRSA infections, without prior kidney injury, proteinuria/hematuria, or other antioxidant/nephrotoxic drug use. Outcomes: Primary: Changes in serum creatinine, NGAL, BUN, creatinine clearance, BUN/creatinine ratio Secondary: Serum potassium/sodium, CRP, total leukocyte count, procalcitonin

Eligibility Criteria

Inclusion Criteria: * Patients admitted to different departments of the hospital * Both genders, aged ≥18 years * Susceptibility to gram-positive infection (MRSA) requiring vancomycin treatment for at least 7 days * Not receiving any concurrent antioxidant treatment (e.g., vitamin E) * Free of proteinuria and/or hematuria * No prior history of acute kidney injury (AKI) Exclusion Criteria: * Known allergy to vancomycin, ascorbic acid, or rutin * Pregnant or lactating females * Baseline serum creatinine ≥2 mg/dL * Receiving other nephrotoxic drugs at time of initiating vancomycin (e.g., aminoglycosides, colistin, amphotericin B, tacrolimus, cisplatin, or calcineurin inhibitors) * Urinary tract stones * Expected to undergo contrast medium administration within 7 days

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Source: ClinicalTrials.gov (NCT07873372). StuddyBuddy aggregates publicly available trial information.