BackgroundCatheter-related bloodstream infections (CRBSI) are associated with increased morbidity and mortality in hemodialysis patients (HD). Cathasept (Tetra-sodium EDTA) solution has antimicrobial and anticoagulant activities.
Study DesignMulti-center, prospective, randomized, and controlled study.
Setting & Participants117 maintenance HD patients with confirmed uncolonised tunneled hemodialysis catheters (t-HDC) were recruited from four hemodialysis centers.
InterventionPatients were randomly assigned to remain on heparin 5000 units/ml locks (Heparin Group -HG) or to receive Cathasept 4% locks (Cathasept Group -CG) thrice weekly according to the catheter lumen volume and were followed up until their catheter was removed or for a maximum of 8 months.
OutcomesPrimary outcome was the incidence rate of clinically significant microbial colonization of t-HDC defined as through-catheter quantitative blood culture (TCQBC) yielding ≥1000 CFU/ml of bacteria or yeast. Secondary outcomes included CRBSI rate, catheter patency, and biomarkers of inflammation and anemia.
MeasurementsWeekly TCQBC. hs-CRP was measured fortnightly, and FBC and Ferritin monthly.
ResultsCatheter colonization rate was 0.14/1000 catheter-days in the CG and 1.08/1000 catheter-days in the HG [Incidence rate ratio (IRR) 0.13; 95% CI, 0.003-0.94; p=0.02]. CRBSI rate was 0.28/1000 catheter-days in the CG and 0.68/1000 catheter 4 days in the HG [IRR 0.40; 95% CI, p=0.3]. The proportion of dialysis sessions with achieved prescribed blood flow rate was significantly lower in the CG (66.8% vs 75.3%; p<0.001), with more patients required thrombolytic locks or infusion to maintain catheter patency (22 vs 9; p=0.01). On average, hs-CRP was 11.6 (SE ±5.3) mg/l lower for patients in the HG (p=0.03). Anemia markers were comparable in both groups.
LimitationsThe study was underpowered to assess the effect on CRBSI, was terminated early due to slow recruitment, and was not double-blinded.
ConclusionCathasept significantly reduced t-HDC colonization but the reduction in CRBSI was not statistically significant, and it was associated with more thrombotic complications.Its safety profile was comparable to heparin lock solution.