title: Multicenter clinical trial results with the LifeSite hemodialysis access system.
abstract: BACKGROUND
  The LifeSite Hemodialysis Access System is a subcutaneous access device designed to maximize blood flow while minimizing access-related complications. The purpose of this study was to compare the efficacy and safety of the LifeSite System to a similar but transcutaneous access device, the Tesio-Cath Hemodialysis Catheter.
  
  
  METHODS
  The study was conducted in two phases. A multi-center randomized prospective design was utilized for the first phase (Phase 1) where thirty-four patients were enrolled in the Tesio-Cath group and 36 patients into the LifeSite group where 0.2% sodium oxychlorosene was used as an antimicrobial solution for the LifeSite. A nonrandomized, but otherwise identical, second phase of the study followed where a 70% isopropyl alcohol solution was utilized as the antimicrobial solution for 34 additional LifeSite patients (Phase 2).
  
  
  RESULTS
  Device function was evaluated in Phase 1 of the trial. Actual blood flow (determined by ultrasound dilution) was greater in the LifeSite versus the Tesio-Cath group (358.7 vs. 331.8 mL/min, P < 0.001 for machine-indicated blood flow of 400 mL/min). Infection comparisons were performed for all three groups encompassing Phase 1 and 2 of the trial; Tesio-Catheter, LifeSite System with oxychlorosene, and LifeSite System with 70% isopropyl alcohol. Device-related infections were defined as systemic bacteremia without another obvious site of origin and exit site infections requiring systemic antibiotics or device removal. This revealed infection rates per 1000 device use days of 1.3 for the LifeSite alcohol group, 3.3 for the Tesio-Cath group, and 3.4 per for the LifeSite oxychlorosene group. There was no statistically significant difference in device related infection rates between the Tesio-Cath and the LifeSite oxychlorosene groups. There were significant differences in infection rate between LifeSite alcohol group and the other two groups (P < 0.05). Device thrombosis was defined by the need for instillation of thrombolytic agents to maintain blood flow>300 mL/min. There was no difference in the need for thrombolytic infusions between the LifeSite oxychlorosene group and the Tesio-Cath group (P = 0.1496); however, the LifeSite alcohol group required significantly fewer thrombolytic infusions than the Tesio-Cath group (P = 0.0295) to maintain adequate blood flow. Device survival at 6 months after stratification by diabetic status and adjusting for age was significantly better in the LifeSite alcohol group (89.9%) than in the LifeSite oxychlorosene group (64.8%, P = 0.0286) and in the Tesio-Cath (69.1%, P = 0.0292) group.
  
  
  CONCLUSIONS
  The LifeSite Hemodialysis Access System, when used with 70% isopropyl alcohol as an antimicrobial solution, provides superior performance with a lower infection rate and better device survival than a standard cuffed tunneled hemodialysis catheter.
authors.affiliation: Duke University Medical Center, Hospital Box 3014, Durham, NC 27710, USA.
authors.forename: Steve J
authors.initials: SJ
authors.lastname: Schwab
authors.forename: Mark A
authors.initials: MA
authors.lastname: Weiss
authors.forename: Fred
authors.initials: F
authors.lastname: Rushton
authors.forename: John P
authors.initials: JP
authors.lastname: Ross
authors.forename: Jerry
authors.initials: J
authors.lastname: Jackson
authors.forename: Toros
authors.initials: T
authors.lastname: Kapoian
authors.forename: James
authors.initials: J
authors.lastname: Yegge
authors.forename: Melvin
authors.initials: M
authors.lastname: Rosenblatt
authors.forename: Woody J
authors.initials: WJ
authors.lastname: Reese
authors.forename: Ramesh
authors.initials: R
authors.lastname: Soundararajan
authors.forename: Jack
authors.initials: J
authors.lastname: Work
authors.forename: Jamie
authors.initials: J
authors.lastname: Ross
authors.forename: Brian
authors.initials: B
authors.lastname: Stainken
authors.forename: Alexander
authors.initials: A
authors.lastname: Pedan
authors.forename: John A
authors.initials: JA
authors.lastname: Moran
mesh_terms: D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents; D001424:Bacterial Infections / Q000517:prevention & control; D001557:Benzenesulfonates; D002408:Catheters, Indwelling; D003428:Cross Infection / Q000517:prevention & control; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D001557:Benzenesulfonates; C018120:oxychlorosene