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Prospective and comparative study of the lock prophylactic therapy use with gentamicin / cefazolin versus taurolidine / citrate in tunneled catheters for hemodialysis

Grant number: 14/06140-1
Support type:Regular Research Grants
Duration: August 01, 2014 - July 31, 2016
Field of knowledge:Health Sciences - Medicine - Medical Clinics
Principal researcher:Daniela Ponce
Grantee:Daniela Ponce
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil

Abstract

Hemodialysis ( HD ) is the modality of renal replacement therapy more widely used in the world, requiring the availability of adequate vascular access for its realization . Currently, the number of central venous catheters (CV ) has increased as a form of vascular access, parallel to the aging population on dialysis and comorbidities such as diabetes mellitus. Despite the advantage of obtaining immediate access , the strong association with the bloodstream infections and consequent high morbidity and mortality has been directing several studies that purpose is the prevention of infectious events related to the use of CVC in the HD population .The objectives of this study are to compare the efficacy of antibiotic therapy in lock ( gentamicin and cefazolin ) versus the use of taurolidine + citrate concerning the rates of bloodstream infections related to tunneled catheters, as well as evaluate the induction of bacterial resistance in hemodialysis patients and machanical complications associated with the tunneled CVC use in the two treatment groups. This is a prospective and comparative trial that will evaluate the difference in the incidence density of infection in tunneled catheters treated with antibiotic lock therapy versus use of antimicrobial solution without the presence of antibiotics. Study will be performed with prevalent and incident hemodialysis patients using tunneled incident CVC and followed in Dialysis Units of two brazilian hospitals for 24 consecutive months . Patients will be randomized in two groups, according to the prescribed treatment:Group 1 : Patients on antibiotic + heparin lock Group 2 : Patient on taurolidine + heparin + citrate lockPatients remain with the solutions in lock during the interdialytic period, around 48 hours (72h on weekends). Sample size of at least 59 patients in each group was calculated considering an alpha error of 5 % , beta error of 10 % , achieving a statistical power of 80 % and difference detection rate in adverse events of 20 % . (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
VIEIRA BUELONI, TRICYA NUNES; MARCHI, DANIEL; CAETANO, CAMILLE; CAVALCANTE, RICARDO DE SOUZA; MENDES AMARAL, MARCELA LARA; PONCE, DANIELA. Cefazolin-gentamicin versus taurolidine-citrate for the prevention of infection in tunneled central catheters in hemodialysis patients: A quasi-experimental trial. INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, v. 85, p. 16-21, AUG 2019. Web of Science Citations: 1.

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