Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial

Jianhui Zhou, Xueying Cao, Hongli Lin, Zhaohui Ni, Yani He, Menghua Chen, Hongguang Zheng, Xiangmei Chen, Jianhui Zhou, Xueying Cao, Hongli Lin, Zhaohui Ni, Yani He, Menghua Chen, Hongguang Zheng, Xiangmei Chen

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/design: 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.

Discussion: 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.

Trial registration: Clinicaltrials.gov NCT01779557 .

Figures

Fig. 1
Fig. 1
Study design. This is a randomized controlled trial. The eligible patients will be randomly allocated to two groups, Baxter group or HUAREN group. Patients will use Baxter or HUAREN peritoneal dialysis fluid for 5 years. The outcomes will be analyzed and compared. ESRD, end-stage renal disease; PD, peritoneal dialysis
Fig. 2
Fig. 2
Dosage adjustment protocol. The initial dosage is 6 l/day; then the solute clearance, water removal, and clinical manifestation are evaluated. If Kt/V < 1.7, dosage should be increased. If there is a volume overload, salt and water intake, diuretics, and dextrose concentration should be modified before changing dosage. When the dosage is ≥ 12 l/day and Kt/V < 1.7, the treatment adaptation fails. Physicians should be flexible in choosing optimal therapies to protect patients from life-threatening circumstances. The Kt/V and creatinine clearance rate should be re-evaluated 2 weeks after each patient’s situation stabilizes

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