title: Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Peritoneal dialysis is an important type of renal replacement therapy for uremic patients. In peritoneal dialysis, fluids fill in and flow out of the abdominal cavity three to five times per day. Usually, the fluid is packed in a polyvinyl chloride (PVC) bag. Safety concerns have arisen over di-(2-ethylhexyl) phthalate, which is essential in the formation of PVC materials. In 2011, the National Development and Reform Commission of China released a catalog of industrial structural adjustments, mandating the elimination of PVC bags for intravenous infusion and food containers. Although bags for peritoneal dialysis fluid were not included in the elimination list, several manufacturers began to develop new materials for fluid bags. HUAREN peritoneal dialysis fluid consists of the same electrolytes and buffer agent as in Baxter fluid, but is packed in bags that do not contain PVC. This multicenter randomized controlled trial was designed to compare peritoneal dialysis fluid packed in non-PVC-containing and PVC-containing bags. Further, the study sought to determine the proper dose of peritoneal dialysis fluid and the actual survival rates of Chinese patients undergoing peritoneal dialysis.
  
  
  METHODS
  The study participants are adults undergoing continuous ambulatory peritoneal dialysis for 30 days to 6 months. All eligible patients are randomized (1:1) to peritoneal dialysis with Baxter and HUAREN dialysis fluids (initial dose, 6 l/day), with dosages adjusted according to a unified protocol. The primary outcomes are the 1-, 2-, 3-, 4-, and 5-year overall survival rates. Secondary outcome measures include technique survival rates, reductions in estimated glomerular filtration rate, nutritional status, quality of life, cardiovascular events, medical costs and drop-out rates. Safety outcome measures include adverse events, changes in vital signs and laboratory parameters, peritonitis, allergies, and quality of products.
  
  
  CONCLUSIONS
  This study is the first to evaluate the long-term safety and effectiveness of a non-PVC packed peritoneal dialysis fluid. The effects of plasticizer on patient long-term survival will be determined. The characteristics of Chinese patients undergoing peritoneal dialysis will be determined, including proper dose, technique survival rates, patient survival rates, and medical costs.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01779557 .
authors.affiliation: Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, 28 Fuxing Road, Haidian District, Beijing, 100853, China. zhou_joseph@yahoo.com.
authors.forename: Jianhui
authors.initials: J
authors.lastname: Zhou
authors.affiliation: Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, 28 Fuxing Road, Haidian District, Beijing, 100853, China. 18911622536@163.com.
authors.forename: Xueying
authors.initials: X
authors.lastname: Cao
authors.affiliation: Department of Nephrology, First Affiliated Hospital of Dalian Medical University, 222 Zhongshan Road, Zhongshan District, Dalian, Liaoning, Province, 116011, China. linhongli@vip.163.com.
authors.forename: Hongli
authors.initials: H
authors.lastname: Lin
authors.affiliation: Renal Division, Renji Hospital, Shanghai Jiao Tong University School of Medicine, 145 Shandongzhong Road, Huangpu District, Shanghai, 200127, China. profnizh@126.com.
authors.forename: Zhaohui
authors.initials: Z
authors.lastname: Ni
authors.affiliation: Department of Nephrology, Daping Hospital, Third Military Medical University, 10 Changjiangzhilu Daping, Yuzhong District, Chongqing, 400042, China. heynmail@yahoo.com.
authors.forename: Yani
authors.initials: Y
authors.lastname: He
authors.affiliation: Department of Nephrology, General Hospital of Ningxia Medical University, 804 Shenglinan Road, Xingqing District, Yinchuan, Ningxia, Hui Autonomous Region, 750004, China. nxchenmh@163.com.
authors.forename: Menghua
authors.initials: M
authors.lastname: Chen
authors.affiliation: Department of Nephrology, General Hospital of Shenyang Military Command, 83 Wenhua Road, Shenhe District, Shenyang, Liaoning, Province, 110016, China. phd528@163.com.
authors.forename: Hongguang
authors.initials: H
authors.lastname: Zheng
authors.affiliation: Department of Nephrology, Chinese PLA General Hospital, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, 28 Fuxing Road, Haidian District, Beijing, 100853, China. xmchen301@126.com.
authors.forename: Xiangmei
authors.initials: X
authors.lastname: Chen
mesh_terms: D002681:China; D002985:Clinical Protocols; D057186:Comparative Effectiveness Research; D015314:Dialysis Solutions / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D004340:Drug Contamination / Q000517:prevention & control*; D004349:Drug Packaging; D005260:Female; D006304:Health Status; D006699:Home Care Services; D006801:Humans; D007676:Kidney Failure, Chronic / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D008297:Male; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D010968:Plasticizers / Q000737:chemistry*; D011143:Polyvinyl Chloride / Q000737:chemistry*; D011446:Prospective Studies; D012107:Research Design; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015314:Dialysis Solutions; D010968:Plasticizers; D011143:Polyvinyl Chloride