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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemodialysis Catheter Infection

Intervention / Treatment
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* Drug: 0.1% gentamicin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Group 1 (control): Patients using placebo ointment in ES Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1 (control):<br>Patients using placebo ointment at the exit site of the hemodialysis catheter | Drug: Placebo<br>* Patients using placebo ointment at the exit site of the hemodialysis catheter<br>|
| Experimental: Group 2 (intervention)<br>Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter | Drug: 0.1% gentamicin<br>* Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis;, tunneled catheter, central venous catheters, infections, prevention.