A new peritoneal dialysis fluid for Japanese patients: a randomized non-inferiority clinical trial of safety and efficacy
| Autor: | Masao Kim, Mark R. Marshall, Masaaki Nakayama, Noriaki Yorioka, Teruhiko Maeba, Hidemune Naito, Shigeko Hara, Takashi Akiba, Yoshindo Kawaguchi, James A. Sloand |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Dialysis adequacy medicine.medical_specialty Alkalosis Time Factors Physiology medicine.medical_treatment Peritoneal dialysis 030232 urology & nephrology Metabolic alkalosis Urology Renal function 030204 cardiovascular system & hematology Buffers 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Japan Peritoneal Dialysis Continuous Ambulatory Physiology (medical) Internal medicine Dialysis Solutions medicine Humans Lactic Acid Aged Acid-Base Equilibrium Creatinine business.industry Continuous ambulatory peritoneal dialysis Middle Aged medicine.disease Surgery Clinical trial Bicarbonates Treatment Outcome chemistry Nephrology Female Original Article Biocompatibility Peritoneum business |
| Zdroj: | Clinical and Experimental Nephrology |
| ISSN: | 1437-7799 |
| Popis: | 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. Electronic supplementary material The online version of this article (doi:10.1007/s10157-016-1346-9) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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