Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis
Status:
Completed
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
Chronic kidney disease (CKD) is a major public health problem worldwide, with a significant
increase in the number of patients treated with dialysis and renal transplantation.
Hemodialysis (HD) is the most widely used dialysis therapy in the world, and adequate
vascular access is required. The central venous catheter (CVC), although not considered the
ideal vascular access, is still widely used. Its use has a strong relation with
access-related infection, whether it is an exit orifice (IES), a tunnel and the most severe,
the bloodstream (BSI). Consequently CVC contributes to patients' morbidity and mortality in
HD, as well as to the high cost of hemodialysis treatment.
To compare the use of 0.1% topical gentamicin with the use of placebo in the exit site (ES)
of tunneled catheters in patients in chronic HD regarding the reduction in IES and BSI rates
and to identify the induction of bacterial resistance to gentamicin.
Phase:
Phase 1
Details
Lead Sponsor:
Universidade Estadual Paulista Júlio de Mesquita Filho