title: Prevention of tunneled cuffed hemodialysis catheter-related dysfunction and bacteremia by a neutral-valve closed-system connector: a single-center randomized controlled trial.
abstract: BACKGROUND
  Hemodialysis (HD) tunneled cuffed catheters may be fitted with neutral-valve closed-system connectors. Such connectors, which are flushed with saline solution and used for 3 consecutive HD sessions, provide a mechanically closed positive-pressure barrier and potentially may be useful to prevent catheter-related bacteremia and dysfunction.
  
  
  METHODS
  Single-center randomized controlled trial.
  
  
  METHODS
  66 adult HD patients with a tunneled cuffed catheter.
  
  
  METHODS
  Neutral-valve closed-system connector (Tego Needlefree Hemodialysis Connector) versus trisodium citrate, 46.7%, locking solution (Citra-Lock; control group).
  
  
  RESULTS
  Primary composite outcome was the incidence rate of catheter-related dysfunction or bacteremia. Secondary outcomes were the separate incidence rates of catheter-related dysfunction and bacteremia and the cost of both procedures.
  
  
  METHODS
  Catheter dysfunction was defined as the requirement of urokinase and/or a mean blood flow ≤250 mL/min during 2 consecutive HD sessions. Catheter-related bacteremia was defined as ≥2 positive blood cultures. Time of catheter use was calculated and the incidence rate of complications was expressed per 100 person-years.
  
  
  RESULTS
  66 patients were followed up for a median of 86 (IQR, 29-200) days. The composite primary outcome was not significantly reduced in the closed-system-connector intervention group versus the citrate-locking-solution control group (63.56 vs 71.51 per 100 person-years; P = 0.3). Catheter dysfunction in the intervention group was not decreased versus controls (59.59 vs 51.64 per 100-person-years; P = 0.9). Only 6 catheter-related bacteremia events were identified, one in the intervention group (3.97 vs 19.86 per 100 person-years; P = 0.06).
  
  
  CONCLUSIONS
  Small size of the patient population and single-center study.
  
  
  CONCLUSIONS
  Superiority of the closed-system connector in terms of prevention of the primary efficacy end point compared to the standard locking solution was not observed. Further evaluation in a larger study is suggested.
authors.affiliation: Department of Nephrology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Florence
authors.initials: F
authors.lastname: Bonkain
authors.forename: Judith
authors.initials: J
authors.lastname: Racapé
authors.forename: Isabelle
authors.initials: I
authors.lastname: Goncalvez
authors.forename: Micheline
authors.initials: M
authors.lastname: Moerman
authors.forename: Olivier
authors.initials: O
authors.lastname: Denis
authors.forename: Nadia
authors.initials: N
authors.lastname: Gammar
authors.forename: Karine
authors.initials: K
authors.lastname: Gastaldello
authors.forename: Joëlle L
authors.initials: JL
authors.lastname: Nortier
mesh_terms: D000368:Aged; D016470:Bacteremia / Q000209:etiology* / Q000517:prevention & control*; D055499:Catheter-Related Infections / Q000517:prevention & control*; D002408:Catheters, Indwelling / Q000009:adverse effects*; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis / Q000295:instrumentation*