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Cathasept Line Lock and Microbial Colonization of Tunneled Hemodialysis Catheters: A Multicenter Randomized
Muhammad Kanaa1, Mark J Wright2, Habib Akbani3
1Doncaster & Bassetlaw Hospitals NHS Foundation Trust, Doncaster Royal Infirmary, Doncaster, South Yorkshire, United Kingdom.
Insights
Cathasept significantly reduced hemodialysis catheter colonization, but did not significantly lower catheter-related bloodstream infections (CRBSIs). This solution was associated with more thrombotic complications compared to heparin.
Area of Science:
- Nephrology
- Infectious Diseases
- Vascular Access
Background:
- Catheter-related bloodstream infections (CRBSIs) are a significant cause of morbidity and mortality in hemodialysis (HD) patients.
- Cathasept, a tetra-sodium EDTA solution, possesses antimicrobial and anticoagulant properties.
Purpose of the Study:
- To evaluate the efficacy of Cathasept as a catheter lock solution in reducing catheter colonization and CRBSIs in maintenance HD patients.
- To compare the incidence of catheter colonization, CRBSI rates, catheter patency, and inflammatory markers between Cathasept and heparin lock solutions.
Main Methods:
- A multicenter prospective randomized controlled study involving 117 maintenance HD patients with tunneled HD catheters.
- Patients were randomized to receive either Cathasept 4% locks or heparin 5,000 U/mL locks.
- Catheter colonization was assessed weekly via quantitative blood cultures; CRBSI rates, catheter patency, and inflammatory markers were also monitored.
Main Results:
- Cathasept significantly reduced catheter colonization rates compared to heparin (0.14 vs 1.08 per 1,000 catheter-days; P=0.02).
- No statistically significant difference in CRBSI rates was observed between the groups (0.28 vs 0.68 per 1,000 catheter-days; P=0.3).
- The Cathasept group experienced lower dialysis blood flow rates and increased need for thrombolytic interventions, indicating more thrombotic complications.
Conclusions:
- Cathasept effectively reduces tunneled hemodialysis catheter colonization.
- The study was underpowered to demonstrate a significant reduction in CRBSIs and was terminated early.
- Cathasept use was associated with increased thrombotic complications, although its safety profile was comparable to heparin.
Background:
Catheter-related bloodstream infections (CRBSIs) cause morbidity and mortality in hemodialysis (HD) patients. Cathasept (tetra-sodium EDTA) solution has antimicrobial and anticoagulant activities.
Study Design:
Multicenter prospective randomized controlled study.
Setting & Participants:
117 maintenance HD patients with confirmed uncolonized tunneled HD catheters from 4 HD centers.
Intervention:
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.
Outcomes:
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.
Measurements:
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.
Limitations:
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.
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