A novel antimicrobial and antithrombotic lock solution for hemodialysis catheters: a multi-center, controlled, randomized trial.

Catheter-related bloodstream infection is the greatest threat to the safety of patients on hemodialysis. Catheter lock solutions containing heparin have been linked to an increased risk of hemorrhage and thrombocytopenia. To ascertain the safety and efficacy for prevention of catheter-related bloodstream infection and catheter loss from patency failure of a novel catheter lock solution with antimicrobial and antithrombotic activity containing 0.24 M (7.0%) sodium citrate, 0.15% methylene blue, 0.15% methylparaben, and 0.015% propylparaben (C-MB-P), compared with heparin. Multicenter, prospective, randomized, open-label trial with patients studied for up to 6 months. An independent clinical evaluation committee assessing trial outcomes was blinded to patients' treatment assignments. Twenty-five outpatient hemodialysis units. Patients with end-stage renal disease receiving maintenance hemodialysis through a percutaneous cuffed and tunneled internal jugular hemodialysis catheters. Participants' catheters were locked between hemodialysis sessions with the C-MB-P lock solution or sterile saline containing 5000 units of unfractionated heparin (control). We recorded and evaluated catheter-related bloodstream infections, catheter loss attributable to luminal thrombosis, and adverse events. A total of 407 patients participated in the trial (49,565 catheter days), 201 in the C-MB-P group and 206 in the heparin group. Patients in the two lock solution groups were comparable for risk factors predisposing to catheter-related bloodstream infection. Catheters locked with C-MB-P were significantly less likely to cause catheter-related bloodstream infection (0.24 vs. 0.82 per 1000 catheter days; relative risk, 0.29; 95% confidence interval, 0.12-0.70; p = .005) and were less likely to be lost because of patency failure (0 vs. 4; log rank, p = .04). The novel C-MB-P lock solution is well tolerated, significantly reduces the risk of catheter-related bloodstream infection, and provides protection comparable to heparin against patency failure.