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

July 18, 2021 updated by: Camille Pereira Caetano, Universidade Estadual Paulista Júlio de Mesquita Filho

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18.618-970
        • Universidade Estadual Paulista Julio de Mesquita Filho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Group 1 (control):
Patients using placebo ointment at the exit site of the hemodialysis catheter
Drug: Placebo
Patients using placebo ointment at the exit site of the hemodialysis catheter
EXPERIMENTAL: Group 2 (intervention)
Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter
Drug: 0.1% gentamicin
Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of exit-site infection
Time Frame: 1 years
Rates of exit-site infection (measured in events per 1,000 catheter-days)
1 years
Rates of catheter-related bloodstream infections
Time Frame: 1 years
Rates of catheter-related bloodstream infections (measured in events per 1,000 catheter-days)
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

  • Study Director: Daniela Ponce, Universidade Estadual Paulista Julio de Mesquita Filho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2018

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

July 1, 2020

Study Registration Dates

First Submitted

November 30, 2018

First Submitted That Met QC Criteria

July 18, 2021

First Posted (ACTUAL)

July 20, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 18, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98328718.0.0000.5411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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