Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

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

Published in: Trials | Issue 1/2015

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
2.
Wahl HG, Hong Q, Hildenbrand S, Risler T, Luft D, Liebich H. 4-Heptanone is a metabolite of the plasticizer di(2-ethylhexyl) phthalate (DEHP) in haemodialysis patients. Nephrol Dial Transplant. 2004;19:2576–83.CrossRefPubMed
3.
Fischer FP, Machleidt C, Rettenmeier AW, Kuhlmann U, Mettang T. Plasticizers and inhibition of leukocyte function in vitro. Perit Dial Int. 1998;18:620–5.PubMed
4.
Roth Z, Hadas R, Maor Y, Kalo D. In vivo model to examine the long-lasting effects of acute di-(2-ethylhexyl) phthalate (DEHP) exposure on ovarian function in bovine. Reprod Fertil Dev. 2014;27:174.CrossRef
5.
Duty SM, Ackerman RM, Calafat AM, Hauser R. Personal care product use predicts urinary concentrations of some phthalate monoesters. Environ Health Perspec. 2005;113:1530–5.CrossRef
6.
Just AC, Adibi JJ, Rundle AG, Calafat AM, Camann DE, Hauser R, et al. Urinary and air phthalate concentrations and self-reported use of personal care products among minority pregnant women in New York City. J Expo Sci Environ Epidemiol. 2010;20:625–33.CrossRefPubMedPubMedCentral
7.
Romero-Franco M, Hernandez-Ramirez RU, Calafat AM, Cebrian ME, Needham LL, Teitelbaum S, et al. Personal care product use and urinary levels of phthalate metabolites in Mexican women. Environ Int. 2011;37:867–71.CrossRefPubMed
8.
Janjua NR, Frederiksen H, Skakkebaek NE, Wulf HC, Andersson AM. Urinary excretion of phthalates and paraben after repeated whole-body topical application in humans. Int J Androl. 2008;31:118–30.CrossRefPubMed
9.
Buckley JP, Palmieri RT, Matuszewski JM, Herring AH, Baird DD, Hartmann KE, et al. Consumer product exposures associated with urinary phthalate levels in pregnant women. J Expo Sci Environ Epidemiol. 2012;22:468–75.CrossRefPubMedPubMedCentral
10.
Sathyanarayana S, Karr CJ, Lozano P, Brown E, Calafat AM, Liu F, et al. Baby care products: possible sources of infant phthalate exposure. Pediatrics. 2008;121:e260–8.CrossRefPubMed
11.
12.
Mettang T, Thomas S, Kiefer T, Fischer FP, Kuhlmann U, Wodarz R, et al. The fate of leached di(2-ethylhexyl)phthalate in patients undergoing CAPD treatment. Perit Dial Int. 1996;16:58–62.PubMed
13.
Alscher DM, Pauli-Magnus C, Kirchgessner J, Kuhlmann U, Mettang T. A new lactate-based, plasticizer-free, neutral peritoneal dialysis fluid provided in a two-compartment system: effect on peripheral leukocyte function. Nephron. 2000;86:62–9.CrossRefPubMed
14.
Mettang T, Pauli-Magnus C, Alscher DM, Kirchgessner J, Wodarz R, Rettenmeier AW, et al. Influence of plasticizer-free CAPD bags and tubings on serum, urine, and dialysate levels of phthalic acid esters in CAPD patients. Perit Dial Int. 2000;20:80–4.PubMed
15.
Lam MF, Tang C, Wong AK, Tong KL, Yu AW, Li CS, et al. ASPD: a prospective study of adequacy in Asian patients on long term, small volume, continuous ambulatory peritoneal dialysis. Perit Dial Int. 2006;26:466–74.PubMed
16.
Churchill D. Implications of the Canada–USA (CANUSA) study of the adequacy of dialysis on peritoneal dialysis schedule. Nephrol Dial Transplant. 1998;13:s158–63.CrossRef
17.
CANADA–USA (CANUSA) Peritoneal Dialysis Study Group. Adequacy of dialysis and nutrition in continuous peritoneal dialysis: association with clinical outcomes. J Am Soc Nephrol. 1996;7:198–207.
18.
Paniagua R, Amato D, Vonesh E, Correa-Rotter R, Ramos A, Moran J, et al. Effects of increased peritoneal clearances on mortality rates in peritoneal dialysis: ADEMEX, a prospective, randomized, controlled trial. J Am Soc Nephrol. 2002;13:1307–20.PubMed
19.
Paniagua R, Amato D, Vonesh E, Guo A, Mujais S. Health-related quality of life predicts outcomes but is not affected by peritoneal clearance: the ADEMEX trial. Kidney Int. 2005;67:1093–104.CrossRefPubMed
20.
Zhou JH, Ni ZH, Mei CL, Yu XQ, Liu FY, Miao LN, et al. Efficacy and safety of Changfu peritoneal dialysis solution: a multi-center prospective randomized controlled trial. Chin Med J (Engl). 2013;126:4204–9.PubMed
21.
National Kidney Foundation. KDOQI Clinical Practice Guideline for Diabetes and CKD: 2012 update. Am J Kidney Dis. 2012;60:850–86.CrossRef
22.
Chen XM. Complications of peritoneal dialysis. In: Peritoneal Dialysis Standard Operating Procedure (SOP). Beijing: Chinese People’s Military Medical Press; 2010. p. 72–95.
23.
24.
25.
K/DOQI, National Kidney Foundation. Clinical practice guidelines for nutrition in chronic renal failure. Am J Kidney Dis. 2000;35:S1–140.
26.
Ware JEJ, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care. 1992;30:473–83.CrossRefPubMed
27.
Xu Y, Dong J, Zuo L. Is frequency of patient–physician clinic contact important in peritoneal dialysis patients? Perit Dial Int. 2009;29:S83–9.PubMed
28.
Fang W, Qian J, Lin A, Rowaie F, Ni Z, Yao Q, et al. Comparison of peritoneal dialysis practice patterns and outcomes between a Canadian and a Chinese centre. Nephrol Dial Transplant. 2008;23:4021–8.CrossRefPubMed
29.
Fang W, Ni Z, Qian J. Key factors for a high-quality peritoneal dialysis program – the role of the PD team and continuous quality improvement. Perit Dial Int. 2014;34:S35–42.CrossRefPubMedPubMedCentral
30.
Zhang X, Shou Z, Chen Z, Xu Y, Han F, Yin X, et al. The role of an integrated care model for kidney disease in the development of peritoneal dialysis: a single-center experience in China. Perit Dial Int. 2014;34:S55–8.CrossRefPubMedPubMedCentral
31.
Zhang F, Liu H, Gong X, Liu F, Peng Y, Cheng M, et al. Risk factors for mortality in Chinese patients on continuous ambulatory peritoneal dialysis. Perit Dial Int. 2015;35:199–205.CrossRefPubMed
32.
Chen XM, CNRDS group. The annual report of the Chinese National Renal Data System. Beijing: Chinese National Medical Quality Control Center for Kidney Diseases; 2013.
33.
Vonesh EF, Snyder JJ, Foley RN, Collins AJ. Mortality studies comparing peritoneal dialysis and hemodialysis: what do they tell us? Kidney Int. 2006;103:s3–11.CrossRef
34.
Nayak KS, Prabhu MV, Sinoj KA, Subhramanyam SV, Sridhar G. Peritoneal dialysis in developing countries. Contrib Nephrol. 2009;163:270–7.CrossRefPubMed
35.
36.
37.
38.
Zhang L, Wang F, Wang L, Wang W, Liu B, Liu J, et al. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet. 2012;379:815–22.CrossRefPubMed
39.
Xu Y, Wang L, He J, Bi Y, Li M, Wang T, et al. Prevalence and control of diabetes in Chinese adults. JAMA. 2010;2013(310):948–59.
40.
41.
Wang J, Zhang L, Wang F, Liu L, Wang H. China National Survey of Chronic Kidney Disease Working Group. Prevalence, awareness, treatment, and control of hypertension in China: results from a national survey. Am J Hypertens. 2014;27:1355–61.CrossRefPubMedPubMedCentral
42.
Last J, Spasoff RA, Harris S. A Dictionary of Epidemiology. Oxford: Oxford University Press; 2001.
43.
Narikiyo T, Mori Y, Somyo Y, Nakamoto M. Is plasticizer toxic to peritoneal mesothelial cells? Adv Perit Dial. 2007;23:51–6.PubMed
44.
45.
46.
Erythropel HC, Maric M, Nicell JA, Leask RL, Yargeau V. Leaching of the plasticizer di(2-ethylhexyl)phthalate (DEHP) from plastic containers and the question of human exposure. Appl Microbiol Biotechnol. 2014;98:9967–81.CrossRefPubMed
47.
48.
Chinese National Development and Reform Commission. Beijing: Catalogue of Industrial Structure adjustment; 2011.
49.
Chen Z. Good news for end stage renal disease patients. Chin Med J (Engl). 2013;126:4203.PubMed
Metadata
Title
Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial
Authors
Jianhui Zhou
Xueying Cao
Hongli Lin
Zhaohui Ni
Yani He
Menghua Chen
Hongguang Zheng
Xiangmei Chen
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-1131-1

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Study protocol

Telephone-based goal management training for adults with mild traumatic brain injury: study protocol for a randomized controlled trial

Study protocol

Effectiveness of dual-task functional power training for preventing falls in older people: study protocol for a cluster randomised controlled trial

Study protocol

Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial

Study protocol

The effectiveness and safety of plum-blossom needle therapy for Tourette syndrome: study protocol for a randomized controlled trial

Commentary

Recruiting to inpatient-based rehabilitation trials: lessons learned

Study protocol

The use of volatile anesthetic agents for long-term critical care sedation (VALTS): study protocol for a pilot randomized controlled trial