Protective Effects of Montelukast on Vancomycin-Associated Acute Kidney Injury in Children: A Randomized Clinical Trial

Abstract

Background: Vancomycin-associated acute kidney injury (AKI) is a commonly reported adverse event in pediatric patients receiving vancomycin. Objectives: This study evaluated the protective effects of montelukast on vancomycin-induced renal injury in children. Methods: This randomized, double-blind, controlled trial was conducted at Amir Kabir Hospital in Arak, Iran, involving 40 children older than 2 years who were prescribed vancomycin. Participants were randomly assigned (1:1) to receive either montelukast plus standard care or standard care alone. Randomization was performed using a computer-generated sequence, with allocation concealment ensured by sequentially numbered, opaque, sealed envelopes (SNOSE) prepared by an independent researcher. Participants, caregivers, treating physicians, and outcome assessors were all blinded to group assignments. Serum creatinine levels were measured at baseline and three days after starting vancomycin. A change in serum creatinine ≥ 0.3 mg/dL was considered indicative of AKI. This study was funded by Arak University of Medical Sciences (grant No: 6625). Results: Among 40 evaluated cases, the mean ± SD age in the montelukast group was 5.95 ± 3.42 years and in the control group was 5.42 ± 3.50 years. The male-to-female ratio in the montelukast group was 10/10 (50/50%), and in the control group was 8/12 (40/60%). In the montelukast group, creatinine before treatment was 0.68 ± 0.23 mg/dL, and after treatment was 0.39 ± 0.13 mg/dL (P = 0.0001). In the control group, creatinine before treatment was 0.55 ± 0.15 mg/dL, and after treatment was 0.48 ± 0.15 mg/dL (P = 0.080). Conclusions: The results of the present study indicate that montelukast, when administered alongside vancomycin, leads to a decrease in serum creatinine levels in pediatric patients.