Comparative effectiveness of two catheter locking solutions to reduce catheter-related bloodstream infection in hemodialysis patients.
Not Applicable
- Conditions
- Central venous catheter related infections, bacteremia in hemodialysis
- Registration Number
- RBR-6vfg7r
- Lead Sponsor
- Faculdade de Medicina de Botucatu- Unesp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Incident and prevalent patients on hemodialysis; folowed in the dialysis units of Botucatu Clinics Hospital and the Bauru State Hospital; using incident tunneled central venous catheter for hemodialysis
Exclusion Criteria
Patients Under 18; pregnant Women; with other types of dialysis access; with tunneled catheters implanted before November 2014; followed for less than six months after implantation of the catheter; with infection at the time of start of the study
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of bloodstream infection related to tunneled catheters in hemodialysis patients. The infection rate will be calculated by the density of incidence of bloodstream infection in two groups (number of events bloodstream infection per 1000 catheter days).<br>The criteria for bloodstream infection will be the isolation of the same organism in quantitative cultures taken from the distal segment of the catheter and the patient's blood with symptoms of sepsis without another focus or the presence of the same agent for central and peripheral blood cultures<br>The clinical criteria of catheter-related infection will not be considered.<br>Patients will be followed from the catheter insertion until the outcome of the protocol:<br>-Catheter removed due to fistula use or treatment failure of infectious, and mechanical complications related to catheter --Change of dialysis method<br>-Transplantation<br>-Transfer of dialysis center<br>-Patients death.<br>-Finish Follow-up for at least six months
- Secondary Outcome Measures
Name Time Method Emergence of bacterial resistance:<br>Defined as an increase in the number of infections caused by methicillin-resistant Staphylococcus aureus and strains resistant to gentamicin;Mechanical complication of catheter (obstruction): Defined as difficulty to infuse or withdraw fluid from the catheter due to thrombosis, without response with the use of thrombolytic for unblocking. This outcome will be measured by the number of withdrawals of catheter due obstruction or reduced blood flow.