The effect of single dose prophylactic vancomycin before semi-permanent catheterization to prevent catheter related infection; a randomized controlled trial, phase II

Abstract

Introduction: Catheter-related infections are a common complication and a major cause of morbidity and mortality in hemodialysis patients with tunneled central venous catheters. The optimal strategy for the management and prevention of catheter-related infections is unclear. Objectives: This study is aimed to evaluate the single-dose prophylactic vancomycin efficacy before semi-permanent catheterization to prevent catheter-related infection. Patients and Methods: This randomized double-blind controlled clinical trial was conducted on patients with chronic renal failure requiring hemodialysis and insertion of a double-lumen central venous catheter admitted to Ahvaz Golestan Hospital. The intervention group (n=30) received 1 g of vancomycin intravenously one hour before catheter insertion and the control group (n=30) received an equal amount of normal saline. The incidence of catheter-related infections and other complications for 6 months was evaluated. Results: During the 6-month follow-up, hospitalization due to catheter-related infection and the need for antibiotic administration was observed in 9 patients (30.0%) who received vancomycin and 14 patients (46.7%) in the control group (P=0.184). Catheter extraction due to infection was observed in 4 patients of the vancomycin group (13.3%) and 6 patients of the control group (20.7%) (P=0.451). Complications other than infection were observed in four patients (13.3%) in each group (P=1.000). The mean time to onset of infection was 2.43 ±0.38 months in the control group and 3.85 ± 0.42 months in the vancomycin group (P=0.002). Conclusion: Although a single dose of intravenous vancomycin one hour before insertion of a bi-luminal hemodialysis catheter did not show a significant effect on preventing catheter-related infections over 6 months, it significantly delayed the onset of infection. Trial Registration: The trial protocol was approved by Iranian Registry of Clinical Trial (Ethical code: IR.AJUMS.HGOLESTAN.REC.1399.106 and IRCT code: IRCT20201206049617N1; https://www.irct.ir/trial/52832).