Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis

Universidade Estadual Paulista Júlio de Mesquita Filho

Status and phase: Completed; Phase 1

Conditions: Hemodialysis Catheter Infection

Treatments: Drug: Placebo; Drug: 0.1% gentamicin

Study type: Interventional

Funder types: Other

Identifiers

NCT04967859

98328718.0.0000.5411

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• incident and prevalent patients on hemodialysis
• Tunnelled catheter implant within 90 days of study initiation

Exclusion criteria

• patients under 18 years of age
• pregnant women
• other types of access for dialysis other than tunnelled catheters
• course of infection at the time of initiation of the study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Group 1 (control):

Placebo Comparator group

Description:

Patients using placebo ointment at the exit site of the hemodialysis catheter

Treatment:

Drug: Placebo

Group 2 (intervention)

Experimental group

Description:

Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter

Treatment:

Drug: 0.1% gentamicin