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.

Condition(s) studied

Investigational drug(s) / intervention(s)

Rutin + Ascorbic Acid (RUTA C60®): Rutin 60 mg combined with ascorbic acid 160 mg, administered orally as two tablets three times daily. Each dose will be given half an hour before the scheduled vancomycin infusion, continued throughout the 14-day study period. The combination is intended to reduce oxidative stress and inflammation associated with vancomycin-induced nephrotoxicity through the antioxidant properties of both agents.

Ascorbic Acid (C-Retard®): Ascorbic acid 500 mg, administered orally as one sustained-release capsule twice daily. Each dose will be given half an hour before the scheduled vancomycin infusion, continued throughout the 14-day study period. Ascorbic acid is intended to act as an antioxidant, scavenging reactive oxygen species generated by vancomycin therapy to mitigate renal tubular injury.

Study 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

Primary outcome measure(s)

• Change in Serum Creatinine — Daily, from baseline to Day 14
  Measurement of serum creatinine levels to detect changes indicative of vancomycin-induced nephrotoxicity across the three study groups.
• Change in Creatinine Clearance — Daily, from baseline to Day 14
  Creatinine clearance calculated using the Cockcroft-Gault equation (adjusted for body weight/BMI) to assess renal function changes during vancomycin therapy.
• Change in Blood Urea Nitrogen (BUN) — Daily, from baseline to Day 14
  Measurement of BUN levels as a marker of renal function and potential nephrotoxic injury.
• Change in BUN/Creatinine Ratio — Daily, from baseline to Day 14
  Calculated ratio of BUN to serum creatinine to further characterize the nature and severity of renal impairment.
• Change in Plasma NGAL (Neutrophil Gelatinase-Associated Lipocalin) — Baseline, Day 3, and Day 14 (end of study)
  Plasma NGAL measured as an early biomarker of acute kidney tubular injury, prior to changes in serum creatinine.

Trial sites (1)

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