Skip to main content
OpenTrials
Completed

NCT Number: NCT04967859

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemodialysis Catheter Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Universidade Estadual Paulista Júlio de Mesquita Filho

Botucatu, São Paulo, 18.618-970, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.1% gentamicin

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Rates of exit-site infection

    Time frame: 1 years

    Rates of exit-site infection (measured in events per 1,000 catheter-days)

  2. Rates of catheter-related bloodstream infections

    Time frame: 1 years

    Rates of catheter-related bloodstream infections (measured in events per 1,000 catheter-days)

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Registry information

Official study title

Evaluation of the Efficacy of Prophylactic Topical Gentamicin in Tunnelled Catheters for Hemodialysis: a Randomized, Double-blind Clinical Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 20, 2021
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.