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Comparative effectiveness of two catheter locking solutions to reduce catheter-related bloodstream infection in hemodialysis patients.

Comparative effectiveness of catheter locking solutions with gentamicin/cefazolin versus taurolidine to reduce catheter-related infection in hemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6vfg7r
Enrollment
Unknown
Registered
2016-08-11
Start date
2014-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central venous catheter related infections, bacteremia in hemodialysis

Interventions

Group 1-Intervention: 60 patients using tunneled catheters for hemodialysis, newly implanted, making treatment at the Hospital of Botucatu will receive solution in the concentration of gentamicin 5mg
Drug

Sponsors

Faculdade de Medicina de Botucatu- Unesp
Lead Sponsor
Hospital Estadual de Bauru
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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). 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 The clinical criteria of catheter-related infection will not be considered. Patients will be followed from the catheter insertion until the outcome of the protocol: -Catheter removed due to fistula use or treatment failure of infectious, and mechanical complications related to catheter --Change of dialysis method -Transplantation -Transfer of dialysis center -Patients death. -Finish Follow-up for at least six months

Secondary

MeasureTime frame
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.;Emergence of bacterial resistance: Defined as an increase in the number of infections caused by methicillin-resistant Staphylococcus aureus and strains resistant to gentamicin

Countries

Brazil

Contacts

Public ContactDaniela ;Tricya Ponce;Bueloni

Faculdade de Medicina de Botucatu-UNESP;Hospital Estadual de Bauru

dponce@fmb.unesp.br;tbueloni@gmail.com+55(14)99762-5806;+55(14)981554148

Outcome results

None listed

Source: REBEC (via WHO ICTRP)