BACKGROUND:Central venous catheters (CVCs) are used for vascular access in hemodialysis patients who have no alternative access or are awaiting placement or maturation of a permanent access. The major complications of CVCs are catheter-related bloodstream infection and clotting in the catheter lumen. STUDY DESIGN: Parallel-group, randomized, multicenter clinical trial, with patients blinded to study intervention. SETTING & PARTICIPANTS: 16 free-standing dialysis facilities in Northern California belonging to a single provider. 303 adult maintenance hemodialysis patients who were using a tunneled cuffed CVC for vascular access. INTERVENTION: The treatment group received an antibiotic lock containing gentamicin 320 μg/mL in 4% sodium citrate, whereas the control group received the standard catheter lock containing heparin 1,000 U/mL. Both groups received triple-antibiotic ointment on the catheter exit site during dressing changes at each dialysis treatment. OUTCOMES: Catheter-related bloodstream infection and catheter clotting. MEASUREMENTS: Catheter-related bloodstream infection was defined as the occurrence of symptoms consistent with bacteremia together with positive blood culture results in the absence of another obvious source of infection. Catheter clotting was measured as the rate of thrombolytic agent use required to maintain adequate blood flow. A single patient could contribute more than one infection or clotting episode. RESULTS: The rate of catheter-related bloodstream infection was 0.91 episodes/1,000 catheter-days in the control group and 0.28 episodes/1,000 catheter-days in the treatment group (P = 0.003). The time to the first episode of bacteremia was significantly delayed (P = 0.005). The rates of tissue plasminogen activator use were similar in the treatment and control groups: 2.36 versus 3.42 events/1,000 catheter-days, respectively (P = 0.2). LIMITATIONS: The requirement for dialysis facility staff to prepare the treatment intervention prevented a completely blinded study. CONCLUSION:Gentamicin 320 μg/mL in 4% sodium citrate used as a routine catheter lock in CVCs in patients on maintenance hemodialysis therapy markedly decreases the incidence of catheter-related bloodstream infection and is as effective as heparin 1,000 U/mL in preventing catheter clotting.
RCT Entities:
BACKGROUND: Central venous catheters (CVCs) are used for vascular access in hemodialysis patients who have no alternative access or are awaiting placement or maturation of a permanent access. The major complications of CVCs are catheter-related bloodstream infection and clotting in the catheter lumen. STUDY DESIGN: Parallel-group, randomized, multicenter clinical trial, with patients blinded to study intervention. SETTING & PARTICIPANTS: 16 free-standing dialysis facilities in Northern California belonging to a single provider. 303 adult maintenance hemodialysis patients who were using a tunneled cuffed CVC for vascular access. INTERVENTION: The treatment group received an antibiotic lock containing gentamicin 320 μg/mL in 4% sodium citrate, whereas the control group received the standard catheter lock containing heparin 1,000 U/mL. Both groups received triple-antibiotic ointment on the catheter exit site during dressing changes at each dialysis treatment. OUTCOMES: Catheter-related bloodstream infection and catheter clotting. MEASUREMENTS: Catheter-related bloodstream infection was defined as the occurrence of symptoms consistent with bacteremia together with positive blood culture results in the absence of another obvious source of infection. Catheter clotting was measured as the rate of thrombolytic agent use required to maintain adequate blood flow. A single patient could contribute more than one infection or clotting episode. RESULTS: The rate of catheter-related bloodstream infection was 0.91 episodes/1,000 catheter-days in the control group and 0.28 episodes/1,000 catheter-days in the treatment group (P = 0.003). The time to the first episode of bacteremia was significantly delayed (P = 0.005). The rates of tissue plasminogen activator use were similar in the treatment and control groups: 2.36 versus 3.42 events/1,000 catheter-days, respectively (P = 0.2). LIMITATIONS: The requirement for dialysis facility staff to prepare the treatment intervention prevented a completely blinded study. CONCLUSION:Gentamicin 320 μg/mL in 4% sodium citrate used as a routine catheter lock in CVCs in patients on maintenance hemodialysis therapy markedly decreases the incidence of catheter-related bloodstream infection and is as effective as heparin 1,000 U/mL in preventing catheter clotting.
Authors: Ying Wang; Jessica N Ivany; Vlado Perkovic; Martin P Gallagher; Mark Woodward; Meg J Jardine Journal: Cochrane Database Syst Rev Date: 2016-04-04
Authors: Carol L Moore; Anatole Besarab; Marie Ajluni; Vivek Soi; Edward L Peterson; Laura E Johnson; Marcus J Zervos; Elizabeth Adams; Jerry Yee Journal: Clin J Am Soc Nephrol Date: 2014-06-26 Impact factor: 8.237