[Show abstract][Hide abstract] ABSTRACT: Background: Hemodialysis patients are often advised not to shower if they have a central ve-nous catheter (catheter). We developed a shower technique catheter protocol for hemodialysis patients with healed catheter exit sites, designed to permit showering but not increase catheter-related infection risk. Research question: Is it feasible to conduct a randomized control trial comparing the rate of catheter related bacteremia in adult satellite hemodialysis patients using the shower technique protocol versus standard catheter care alone with 6 month follow up? Study Design: This pilot study is a multi-centre randomized control trial. Eligible participants will be randomized to shower technique protocol versus standard care after meeting predefined criteria to confirm healed tunneled catheter exit site. Primary Outcome: Feasibility will be determined by 5 outcome measures: 1) accuracy of the catheter related bacteremia rate documentation in the satellite hemodialysis centre setting, percentage of patients 2) screened, 3) recruited, 4) educated successfully in the shower technique protocol (intervention arm), and 5) treatment contamination of study groups. Study Setting: In 2 academic and 3 community based satellite hemodialysis centres in south central Ontario, Canada. Patient Population: Adult satellite hemodialysis patients dialyzing via tunneled central venous catheters with healed catheter exit sites. Intervention: Shower technique protocol and standard catheter care or control (standard cath-eter care only). Analysis: Each measure of feasibility has its own statistical threshold for success. If the threshold is reached in 4 of the 5 measures, the full study will be deemed feasible. Discussion: A pilot feasibility study of the larger study is critical due to the potential challenges associated with recruitment, compliance and participant ascertainment bias.
[Show abstract][Hide abstract] ABSTRACT: Epoetin alfa (Eprex*; Johnson & Johnson, Manati, PR) has been used successfully to correct the anemia of chronic renal failure for more than 12 years. Anti-erythropoietin (anti-EPO) antibodies have been reported in a small number of patients, resulting in a blood disorder, pure red cell aplasia (PRCA). To evaluate the utility of a large-scale anti-EPO antibody screening program in patients with chronic kidney disease (CKD) administered epoetin alfa, a study involving 5 large renal centers in southern Ontario, Canada, was conducted.
More than 1,500 hemodialysis, peritoneal dialysis, and predialysis patients were screened for the prevalence of anti-EPO antibodies by means of a radioimmunoprecipitation (RIP) assay. Serum samples were drawn and shipped to PPD Development (Richmond, VA) for the immunoprecipitation assay. Serum EPO levels also were measured. All samples that tested positive or borderline for antibodies were sent to MDS Pharma Services (Montreal, Canada) for the neutralization assay.
Of 1,531 samples tested, 1 patient tested low-positive and 3 borderline results were detected by means of RIP. PRCA previously was diagnosed in the patient with the low-positive antibody level; the patient was treated with cyclosporine and currently is being administered epoetin alfa with good response. The 3 patients with borderline antibody results manifested no clinical signs of PRCA. Neutralization assays performed on all 4 serum samples were negative for anti-EPO antibodies.
Results from this surveillance study show that the prevalence of antibody to EPO in patients with CKD administered epoetin alfa in 5 Canadian renal centers is low, and the value of a large-scale antibody screening program for PRCA cannot be justified.
American Journal of Kidney Diseases 09/2004; 44(2):264-9. DOI:10.1053/j.ajkd.2004.04.031 · 5.90 Impact Factor