title: Cathasept Line Lock and Microbial Colonization of Tunneled Hemodialysis Catheters: A Multicenter Randomized Controlled Trial.
abstract: BACKGROUND
  Catheter-related bloodstream infections (CRBSIs) cause morbidity and mortality in hemodialysis (HD) patients. Cathasept (tetra-sodium EDTA) solution has antimicrobial and anticoagulant activities.
  
  
  METHODS
  Multicenter prospective randomized controlled study.
  
  
  METHODS
  117 maintenance HD patients with confirmed uncolonized tunneled HD catheters from 4 HD centers.
  
  
  METHODS
  Patients were randomly assigned to receive Cathasept 4% locks (Cathasept group) or stayed with heparin 5,000 U/mL locks (heparin group), filled thrice weekly according to catheter lumen volume until the catheter was removed or for a maximum of 8 months.
  
  
  RESULTS
  Primary outcome was clinically significant microbial colonization of the catheter, defined as a through-catheter quantitative blood culture yielding ≥ 1,000 colony-forming units/mL of bacteria or yeast. Secondary outcomes included CRBSI rate, catheter patency, and biomarkers of inflammation and anemia.
  
  
  METHODS
  Weekly through-catheter quantitative blood culture, high-sensitivity C-reactive protein fortnightly, and full blood count and ferritin monthly.
  
  
  RESULTS
  Incidence rates of catheter colonization were 0.14/1,000 catheter-days in the Cathasept group and 1.08/1,000 catheter-days in the heparin group (incidence rate ratio [IRR], 0.13; 95% CI, 0.003-0.94; P=0.02). CRBSI rates were 0.28/1,000 catheter-days in the Cathasept group and 0.68/1,000 catheter days in the heparin group (IRR, 0.40; 95% CI, 0.08-2.09; P=0.3). The proportion of dialysis sessions with achieved prescribed blood flow rate was significantly lower in the Cathasept group (66.8% vs 75.3%; P<0.001), with more patients requiring thrombolytic locks or infusions to maintain catheter patency (22 vs 9; P=0.01). Mean high-sensitivity C-reactive protein level was 11.6±5.3 (SE) mg/L lower for patients in the heparin group (P=0.03). Anemia marker levels were similar in both groups.
  
  
  CONCLUSIONS
  Study was underpowered to assess effect on CRBSI, terminated early due to slow recruitment, and not double blinded.
  
  
  CONCLUSIONS
  Cathasept significantly reduced tunneled hemodialysis catheter colonization, but the reduction in CRBSIs was not statistically significant, and it was associated with more thrombotic complications. Its safety profile was comparable to heparin lock solution.
authors.affiliation: Doncaster & Bassetlaw Hospitals NHS Foundation Trust, Doncaster Royal Infirmary, Doncaster, South Yorkshire, United Kingdom. Electronic address: muhammad.kanaa@dbh.nhs.uk.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Kanaa
authors.affiliation: Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Wright
authors.affiliation: Bradford Teaching Hospitals NHS Foundation Trust, Bradford, United Kingdom.
authors.forename: Habib
authors.initials: H
authors.lastname: Akbani
authors.affiliation: York Teaching Hospital NHS Foundation Trust, York, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Laboi
authors.affiliation: Hull and East Yorkshire Hospitals NHS Trust and Hull York Medical School, Hull, United Kingdom.
authors.forename: Sunil
authors.initials: S
authors.lastname: Bhandari
authors.affiliation: Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom; University of Leeds, Leeds, United Kingdom.
authors.forename: Jonathan A T
authors.initials: JA
authors.lastname: Sandoe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D055499:Catheter-Related Infections / Q000175:diagnosis* / Q000453:epidemiology; D002405:Catheterization, Central Venous / Q000009:adverse effects*; D062905:Central Venous Catheters / Q000009:adverse effects* / Q000382:microbiology*; D004311:Double-Blind Method; D004492:Edetic Acid / Q000008:administration & dosage*; D005260:Female; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D006493:Heparin; D004492:Edetic Acid
keywords: Cathasept; EDTA; Hemodialysis; antimicrobial; bacteremia; bacteria; catheter lock; catheter-related bloodstream infection (CRBSI); central venous catheters; colonization; end-stage renal disease (ESRD); heparin; inflammation; patency; yeast