Hemodialysis Catheter Infection
Conditions
Keywords
hemodialysis;, tunneled catheter, central venous catheters, infections, prevention.
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.
Interventions
DRUG0.1% gentamicin
Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter
DRUGPlacebo
Patients using placebo ointment at the exit site of the hemodialysis catheter
Sponsors
Universidade Estadual Paulista Júlio de Mesquita Filho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients will be allocated to two groups randomly (draw), according to the prescribed topical treatment (gentamicin or placebo). The randomization protocol will be generated by an individual other than the patients' clinical follow-up using specific software (randomization). . The randomization list as well as the identification of the bottles and the uniformity of the packages will remain under the care of the researchers who are not familiar with the patients' clinical follow-up
Intervention model description
Group 1 (control): Patients using placebo ointment in ES Group 2 (intervention): Patient using 0.1% gentamicin ointment in ES
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Brazil
Outcome results
None listed