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

Phase 1

Completed

• Conditions: Hemodialysis Catheter Infection
• Interventions: Drug: Placebo; Drug: 0.1% gentamicin

• Registration Number: NCT04967859
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-11-30
• Primary Completion: 2019-11-01
• Study Completion: 2020-07-01
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-18
• Last Update Submitted: 2021-07-18
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (control):	Placebo	Patients using placebo ointment at the exit site of the hemodialysis catheter
Group 2 (intervention)	0.1% gentamicin	Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter

Primary Outcome Measures

Name	Time	Method
Rates of exit-site infection	1 years	Rates of exit-site infection (measured in events per 1,000 catheter-days)
Rates of catheter-related bloodstream infections	1 years	Rates of catheter-related bloodstream infections (measured in events per 1,000 catheter-days)

Trial Locations

Locations (1)

Universidade Estadual Paulista Júlio de Mesquita Filho; 🇧🇷 Botucatu, São Paulo, Brazil