A randomized trial comparing gentamicin/citrate and heparin locks for central venous catheters in maintenance hemodialysis patients.

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.

Analysis of factors associated with statin adherence in a hierarchical model considering physician, pharmacy, patient, and prescription characteristics.

BACKGROUND: Adherence with maintenance drug therapy such as HMG-CoA reductase inhibitors (statins) is typically analyzed from the perspective of patient characteristics. OBJECTIVE: To determine the effects of physician and pharmacy characteristics in addition to patient characteristics on variation in adherence rates for 4 statin drugs (atorvastatin, pravastatin, rosuvastatin, and simvastatin) for patients who patronized only 1 pharmacy and 1 prescriber of a statin. METHODS: A retrospective cohort study of 6,436 patients who initiated statin therapy was performed from computerized pharmacy records of 2 large national pharmacy chains. Adherence was defined as the number of 30-day refills within 12 months after initiation of statin therapy. Physician, pharmacy, prescription, and patient covariates were considered in a cross-classified hierarchical regression model. RESULTS: The average number of refills dispensed was 4.75 per patient. Patients younger than 50 years had, on average, 13.6% fewer refills per year than did patients older than 70 years (P<0.001). Women were 4.4% less adherent than men (P = 0.041). Patients residing in southern states were significantly less adherent than were other patients; they had 19.4% fewer refills per year than did patients from western states (P<0.001). Each prescription dispensed for comorbid conditions increased adherence by 2.0% (P =0.002), and patients with a history of cardiovascular drug use were 14.1% more adherent than were other patients (P <0.001). Patients on a higher statin dose appeared to be 8.4% less adherent than were patients on a lower dose (P <0.001). Adherence was greater as the number of prescribed refills increased, with a rate of 2.1% per refill (P <0.001). Adherence was lower for patients with higher copayments, with a rate of 2.2% per each additional $10 of copayment (P <0.001). For patients treated by physicians in the top 2.5 percentile and bottom 2.5 percentile of statin adherence, mean refill counts per year were 6.1 and 2.9, respectively. For patients who patronized pharmacies in the top 2.5 percentile and bottom 2.5 percentile of statin adherence, mean refill counts per year were 6.6 and 2.5, respectively. Adherence increased at a rate of 28.4% per each additional 100 statin patients per patronized pharmacy (P <0.001) and decreased at a rate of about 6.5% per each additional 10 statin patients per treating physician (P <0.001). CONCLUSION: Because of the variability in adherence rates across pharmacies and physicians, further assessment of pharmacy and physician characteristics in addition to patient characteristics may be of value in improving adherence.

Efficacy and safety results with the LifeSite hemodialysis access system versus the Tesio-Cath hemodialysis catheter at 12 months.

PURPOSE: To compare the performance and safety of a fully subcutaneous vascular access device, the LifeSite hemodialysis access system, versus a tunneled hemodialysis catheter, the Tesio-Cath, at 1 year after implantation. MATERIALS AND METHODS: Sixty-eight patients who required hemodialysis received implantation of the LifeSite device or a Tesio-Cath device as a part of this multicenter study. Thirty-four patients were treated in each group. The endpoints observed included blood flow rates and associated venous pressures, overall and device-related adverse events, the need for thrombolytic infusions, device-related infections (DRIs) and associated hospitalizations, and technical device survival. RESULTS: During the 12-month observation period, significantly higher venous pressures were required in patients with the Tesio-Cath to achieve blood flow rates comparable with those achieved with the LifeSite device. Patients in the LifeSite group experienced a significantly lower rate of non-device-related adverse events (P < .001), device-related adverse events (P < .016), need for thrombolytic infusions (P < .002), and DRIs (P < .013) compared with patients in the Tesio-Cath group. There was a trend toward a lower number of hospital days per month for DRIs in the LifeSite group, with the rate for the Tesio-Cath group being twice that in the LifeSite group. The use of the LifeSite device was also associated with a significantly higher probability of device survival for 12 months after censoring for planned removals (P < .031). CONCLUSIONS: The results of the present study demonstrate superior device performance and technical device survival, reduced complications, and the need for fewer interventions with the LifeSite hemodialysis access system compared with a standard hemodialysis catheter during a 1-year time period after implantation.

End-stage renal disease-associated managed care costs among patients with and without diabetes.

OBJECTIVE: To examine the direct costs of care before and after onset of end-stage renal disease (ESRD) for patients with and without diabetes based on analyses of retrospective healthcare claims data. RESEARCH DESIGN AND METHODS: Patients with onset of ESRD between January 1998 though June 2002 were identified based on use of dialysis, renal transplantation, or other ESRD-related services. Continuous health plan enrollment > or =12 months before and > or =1 month after ESRD onset was required. The costs calculated include both observed and adjusted estimates; the latter were calculated using generalized linear models, controlling for demographic and clinical characteristics, "onset" period, and duration of follow-up. Analyses focus on the diabetic ESRD patient and include a comparison with ESRD patients without diabetes. RESULTS: The study included 2,020 patients with diabetes and 2,170 without diabetes; 63% of patients were >50 years of age. Average costs were relatively stable before ESRD ($1,535 to $4,357 for diabetes, $1,082 to $2,447 for no diabetes) but more than doubled in the month preceding onset ($9,152 and $8,211, respectively). Postonset, average monthly per-patient costs escalated sharply in the 1st month ($26,507 and $26,789), declined steadily through month 6, and remained flat but elevated thereafter. Adjusted annual costs per patient pre- and postonset of ESRD were significantly higher for diabetes (P <0.0001); annual costs were 69% ($38,041 vs. $22,538) and 79% ($96,014 vs. $53,653) higher pre- and postonset, respectively. CONCLUSIONS: The economic burden of ESRD in the year after onset is substantial, particularly among patients with diabetes.

Sinus versus nonsinus tachycardia in the emergency department: importance of age and heart rate.

BACKGROUND: The emergency department diagnosis of sinus versus nonsinus tachycardia is an important clinical challenge. The objective of this study was to identify subjects with a high prevalence of nonsinus tachycardia. METHODS: Heart rate and cardiac rhythm were prospective reviewed in 500 consecutive patients with heart rate > or = 100 beats/min in a busy emergency department. A predictive model based on age and heart rate was then developed to identify the probability of nonsinus tachycardia. RESULTS: As age and heart rate increased, nonsinus tachycardias became more frequent. The probability of nonsinus tachycardia in a subject > or = 71 years with heart rate > or = 141 beats/minute was 93%, compared to only three percent in a subject < or = 50 years with heart rate 100-120 beats/minute. A simple point score system based on age and heart rate helps predict the probability of sinus tachycardia versus nonsinus tachycardia. CONCLUSION: Nonsinus tachycardia is significantly more common than sinus tachycardia in elderly patients in the emergency department. The diagnosis of sinus tachycardia becomes much less likely as age and heart rate increase.

Multicenter clinical trial results with the LifeSite hemodialysis access system.

BACKGROUND: The LifeSite Hemodialysis Access System is a subcutaneous access device designed to maximize blood flow while minimizing access-related complications. The purpose of this study was to compare the efficacy and safety of the LifeSite System to a similar but transcutaneous access device, the Tesio-Cath Hemodialysis Catheter. METHODS: The study was conducted in two phases. A multi-center randomized prospective design was utilized for the first phase (Phase 1) where thirty-four patients were enrolled in the Tesio-Cath group and 36 patients into the LifeSite group where 0.2% sodium oxychlorosene was used as an antimicrobial solution for the LifeSite. A nonrandomized, but otherwise identical, second phase of the study followed where a 70% isopropyl alcohol solution was utilized as the antimicrobial solution for 34 additional LifeSite patients (Phase 2). RESULTS: Device function was evaluated in Phase 1 of the trial. Actual blood flow (determined by ultrasound dilution) was greater in the LifeSite versus the Tesio-Cath group (358.7 vs. 331.8 mL/min, P < 0.001 for machine-indicated blood flow of 400 mL/min). Infection comparisons were performed for all three groups encompassing Phase 1 and 2 of the trial; Tesio-Catheter, LifeSite System with oxychlorosene, and LifeSite System with 70% isopropyl alcohol. Device-related infections were defined as systemic bacteremia without another obvious site of origin and exit site infections requiring systemic antibiotics or device removal. This revealed infection rates per 1000 device use days of 1.3 for the LifeSite alcohol group, 3.3 for the Tesio-Cath group, and 3.4 per for the LifeSite oxychlorosene group. There was no statistically significant difference in device related infection rates between the Tesio-Cath and the LifeSite oxychlorosene groups. There were significant differences in infection rate between LifeSite alcohol group and the other two groups (P < 0.05). Device thrombosis was defined by the need for instillation of thrombolytic agents to maintain blood flow>300 mL/min. There was no difference in the need for thrombolytic infusions between the LifeSite oxychlorosene group and the Tesio-Cath group (P = 0.1496); however, the LifeSite alcohol group required significantly fewer thrombolytic infusions than the Tesio-Cath group (P = 0.0295) to maintain adequate blood flow. Device survival at 6 months after stratification by diabetic status and adjusting for age was significantly better in the LifeSite alcohol group (89.9%) than in the LifeSite oxychlorosene group (64.8%, P = 0.0286) and in the Tesio-Cath (69.1%, P = 0.0292) group. CONCLUSIONS: The LifeSite Hemodialysis Access System, when used with 70% isopropyl alcohol as an antimicrobial solution, provides superior performance with a lower infection rate and better device survival than a standard cuffed tunneled hemodialysis catheter.