A new peritoneal dialysis fluid for Japanese patients: a randomized non-inferiority clinical trial of safety and efficacy.

BACKGROUND: We report here two new peritoneal dialysis fluids (PDFs) for Japan [BLR 250, BLR 350 (Baxter Limited, Japan)]. The PDFs use two-chamber systems, and have bicarbonate and lactate buffer to a total of 35 mmol/L. In separate trials, the new PDFs were compared to two "standard" systems [PD-4, PD-2 (Baxter Limited, Japan)]. The trials aimed to demonstrate non-inferiority of peritoneal creatinine clearance (pCcr), peritoneal urea clearance (pCurea) and ultrafiltration volume (UF), and compare acid-base and electrolyte balance. METHODS: We performed randomized, multicenter, parallel group, controlled, open-label clinical trials in stable continuous ambulatory peritoneal dialysis (CAPD) patients. The primary endpoints were pCcr and UF. The secondary endpoints were serum bicarbonate and peritoneal urea clearance. The active phase was 8 weeks. These trials were performed as non-inferiority studies, with the lower limit of non-inferiority for pCcr and UF set at 3.2 L/week/1.73 m2 and 0.12 L/day, respectively. RESULTS: 108 patients (28 centers) and 103 patients (29 centers) took part in the two trials. Groups were well balanced at baseline. The investigative PDFs were non-inferior to the "standard" ones in terms of primary endpoints, comparable in terms of pCurea, and superior in terms acid-base balance, especially correcting those with over-alkalinization at baseline. CONCLUSIONS: We demonstrated fundamental functionality of two new PDFs and showed superior acid-base balance. Given the propensity of Japanese CAPD patients for alkalosis, it is important to avoid metabolic alkalosis which is associated with increased cardiovascular mortality risk and accelerated vascular calcification. The new PDFs are important progress of CAPD treatment for Japanese patients.

2005 Japanese Society for Dialysis Therapy guidelines for vascular access construction and repair for chronic hemodialysis.

The guideline committee of Japanese Society for Dialysis Therapy (JSDT), chaired by Dr Ohira, has published an original Japanese guideline, 'Guidelines for Vascular Access Construction and Repair for Chronic Hemodialysis'. The guideline was created mainly because of the existence of numerous factors characteristic of Japanese hemodialysis therapy, which are described in this report, and because we recognized the necessity for standardization in vascular access-related surgeries. This guideline consists of 10 chapters, each of which includes guidelines, explanations or comments and references. The first chapter discusses informed consent of vascular access (VA)-related surgeries, which often resulted in trouble between dialysis staff and patients. The second chapter describes the fundamentals of VA construction and timing of the introduction of hemodialysis with emphasis on the avoidance of catheter indwelling if at all possible. In the third chapter, arteriovenous fistula (AVF) construction and management are discussed from the viewpoint of the most preferable type of VA. The fourth chapter deals with arteriovenous grafts (AVG) which has recently increased in clinical applications. The factors which improve the AVG patency rate are discussed and postoperative management methods are emphasized to avoid possible complications. The fifth chapter deals with short and long-term vascular catheters. It is emphasized that these methods are definitely effective but, at the same time, are apt to be associated with several serious complications and might result in vascular damage. In the sixth chapter, superficialization of an artery is explained. This was originally for emergency use or backup but has been used permanently in 2-3% of Japanese hemodialysis patients. In the seventh chapter, methods for the use of VA are described and the buttonhole method is referred to as one of the options for patients who complain of intense pain at every cannulation. In the eighth chapter, the importance of continuous monitoring is stressed for maintaining appropriate function of VA. As a rule, the internal shunt type VA (AVF, AVG) places a burden on cardiac function. Thus, in the ninth chapter, it is stressed that VA construction, maintenance and repair should always be carried out with consideration of cardiac function which is not constant but variable. The 10th chapter forms one of the cores of this guideline and deals with repair and timing of VA. It is shown how to select a surgical or interventional repair method. In the final 11th chapter, VA types and resultant morbidity and mortality of hemodialysis patients are reviewed.

The Japanese health-care system and reimbursement for dialysis.

Like most countries, Japan is facing constraints on expansion of health system financial resources. There are almost 250000 Japanese patients with end-stage renal disease and almost all are managed by chronic dialysis. Hospital hemodialysis is the modality used by 96% of these patients. The Japanese health-care system has tended to support resource-intensive treatments because the fee-for-service remuneration system has rewarded their utilization. This has benefited hemodialysis at the expense of peritoneal dialysis. However, this may now be changing. Case management and global budget-related approaches are being more widely introduced, as are incentives to reward more efficient treatment options. The relative costs of dialysis modalities are difficult to appreciate, as center-based services, such as hospital hemodialysis, are dependent upon fixed resources, while home-based options, such as peritoneal dialysis, are dependent upon variable resources. The aim of this review is to reconcile various sources of information relevant to end-stage renal disease funding in Japan. The review will suggest that modifying the approach to modality selection could lead to more efficient allocation of future dialysis-related resources and so reduce the strain on Japan's health-care budget.

Markers in peritoneal effluent for withdrawal from peritoneal dialysis: multicenter prospective study in Japan.

The most serious problem in peritoneal dialysis (PD) is the risk of final complication by encapsulating peritoneal sclerosis (EPS) because of peritoneal deterioration. Markers useful for the noninvasive evaluation ofperitoneal deterioration are therefore required. In this multicenter prospective study of stable PD patients, we compared the dialysate-to-plasma (D/P) concentration ratios of albumin, immunoglobulin G, and c2-macroglobulin, and effluent levels of interleukin 6 (IL-6) and fibrinogen/fibrin degradation products (FDPs) to clarify the relationship between inflammation, fibrinolysis markers, and permeability to large molecules. At the beginning of the present study, significantly positive correlations were noted between the IL-6 and FDP concentrations and the D/P ratios of albumin and a2-macroglobulin. In addition, a significantly positive correlation was noted between the FDP and IL-6 concentrations. However, the D/P ratio of creatinine obtained by peritoneal equilibration test did not positively correlate with those markers. Moreover, a significantly positive correlation was noted between changes in the effluent concentrations of FDPs and IL-6 and in permeability markers for large molecules. The effluent IL-6 and FDP concentrations reflect a chronic inflammatory state in the peritoneum, which is associated with increased permeability to large molecules. In individual PD patients, careful observation of the clinical course and evaluation of changes in such markers are expected to predict peritoneal deterioration and the development of EPS.