Clinical Trials Logo
  1. Home
  2. Hemodialysis Catheter Infection
  3. NCT04967859

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

Hemodialysis Catheter Infection Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04967859
Study type Interventional
Source Universidade Estadual Paulista Júlio de Mesquita Filho
Contact
Status Completed
Phase Phase 1
Start date July 1, 2018
Completion date July 1, 2020
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04054128 - Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients Phase 4
Completed NCT03039777 - Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients N/A
Terminated NCT05670964 - Evaluation of the Impact of the UPLUG Device Onto the Infection Rate of Indwelling Central Venous Catheters in Patients Undergoing Chronic Hemodialysis N/A
Completed NCT03627884 - Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation Phase 4
Recruiting NCT06093269 - Pharmacokinetics Study of Cefazolin in Hemodialysis (CEFAZODIAL) Phase 4
Completed NCT05855616 - Chlorhexidine Dressings for Hemodialysis Catheter Exit Site Care: Comparative Study N/A
Terminated NCT05228132 - The Pristine Post-Market Study N/A
Recruiting NCT03539718 - Taurolock Hep 500 Versus Unfractionated Heparin as Anti-inflammatory in Hemodialysis Catheters. Phase 4
Not yet recruiting NCT03425448 - Neutrolin Versus Heparin for Locking Hemodialysis Catheters N/A
Completed NCT05874219 - Mupirocin 2% Ointment Vs Spray Antibiotics on Temporary Hemodialysis Catheter Phase 2/Phase 3