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.
A randomized, double-blind clinical trial comparing the use of 0.1% gentamicin versus placebo in the ES of tunnelled catheters for hemodialysis in the prevalence and density of incidence of IES and BSI. Patients will be allocated into two groups randomly: Group 1 (control): Patients using placebo ointment in ES; Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
90
Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter
Patients using placebo ointment at the exit site of the hemodialysis catheter
Universidade Estadual Paulista Júlio de Mesquita Filho
Botucatu, São Paulo, Brazil
Rates of exit-site infection
Rates of exit-site infection (measured in events per 1,000 catheter-days)
Time frame: 1 years
Rates of catheter-related bloodstream infections
Rates of catheter-related bloodstream infections (measured in events per 1,000 catheter-days)
Time frame: 1 years
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