Could melatonin prevent Vancomycin-induced nephrotoxicity in critically ill patients? A randomized, double-blinded controlled trial

Background: Previous research showed some clinical benefits regarding the nephroprotective effect of melatonin. So, this study aimed to evaluate the beneficial effect of oral melatonin on preventing acute kidney injury (AKI) in patients who received vancomycin therapy in the intensive care unit (ICU).Methods: We performed a randomized, double-blinded, placebo-controlled pilot study in an academic hospital. Adult patients admitted to the ICU who received vancomycin with normal gastrointestinal and kidney function were randomized into treatment or placebo groups. After that, enrolled patients received a tablet of melatonin (3 mg) or placebo twice daily for seven consecutive days. The occurrence of AKI was assessed by RIFLE criteria (by measurement of serum creatinine (SCr)) and plasma neutrophil gelatinase-associated lipocalin (NGAL) concentration. Moreover, other data related to renal functions and SOFA were also compared between groups.Results: A total of 90 patients were included in the study, while 21patients in the placebo group and 20 in the intervention group completed the study. There were no significant differences between groups regarding baseline SCr, BUN, urine output, NGAL, SOFA, and glomerular filtration rate (GFR). Our results showed that these differences remained insignificant after a 7-day follow-up between groups. However, the incidence of AKI was significantly lower in the melatonin group based on the NGAL cutoff (> 150 ng/mL). Conclusion: We detected a significant decrease in vancomycin-induced nephrotoxicity incidence in patients receiving melatonin compared to placebo. However, more clinical trials in a larger population were required to confirm this result.