Superior patient survival for continuous ambulatory peritoneal dialysis patients treated with a peritoneal dialysis fluid with neutral pH and low glucose degradation product concentration (Balance).
BACKGROUND
In recent years, laboratory and clinical research has suggested the need for peritoneal dialysis fluids (PDFs) that are more biocompatible than the conventional PDFs commonly used today. Bioincompatibility of PDF has been attributed to low pH, lactate, glucose, glucose degradation products (GDPs), and osmolality. PDFs with neutral pH and low GDPs are now available commercially. In vitro and early clinical studies suggest that these solutions are indeed more biocompatible but, as of now, there is no evidence that their use improves patient outcome.


METHODS
Using a dedicated database of over 2000 patients treated with PD in Korea, we were able to conduct a retrospective observational study comparing outcomes for incident continuous ambulatory PD patients treated with a standard, conventional, heat-sterilized PDF to the outcomes for patients treated with a novel, low GDP, neutral-pH PDF prepared in a dual-compartment, double-bag PD system (Balance; Fresenius Medical Care, St. Wendel, Germany). In an intention-to-treat analysis, patient and technique survival, peritonitis-free survival, and peritonitis rates were compared in 611 patients treated with Balance for up to 30 months and 551 patients with a standard PDF (stay . safe; Fresenius Medical Care) treated in the same era and with equivalent follow-up.


RESULTS
The patients were well matched for most relevant characteristics except older age distribution for the patients treated with the standard PDF. Patients treated with Balance had significantly superior survival compared to those treated with the standard PDF (74% vs 62% at 28 months, p = 0.0032). In a multivariate Cox regression model including age, diabetes, and gender, the survival advantage persisted (relative risk of death for Balance 0.75, 95% confidence interval 0.56 - 0.99, p = 0.0465). Modality technique survival was similarin Kaplan-Meieranalysis for both PDFs. No differences were detected in peritonitis-free survival or in peritonitis rates between the two solutions.


CONCLUSIONS
This study, for the first time, suggests that treatment with a novel biocompatible PDF with low GDP concentration and neutral pH confers a significant survival advantage. The exact mechanisms for such a survival advantage cannot be determined from this study. The usual criticisms of observational studies apply and the results reported here strongly warrant the undertaking of appropriately designed, randomized, controlled clinical trials.
Lee
Ho Yung
HY
Department of Internal Medicine, Yonsei University College of Medicine, CPO Box 8044, Seoul, Korea. hyl@yumc.yonsei.ac.kr
Park
Hyeong Cheon
HC
Seo
Bo Jeung
BJ
Do
Jun Young
JY
Yun
Sung Ro
SR
Song
Hyun Yong
HY
Kim
Yeong Hoon
YH
Kim
Yong Lim
YL
Kim
Dae Joong
DJ
Kim
Yong Soo
YS
Ahn
Curie
C
Kim
Moon Jae
MJ
Shin
Sug Kyun
SK
D000328:Adult; D000368:Aged; D015314:Dialysis Solutions / Q000737:chemistry*; D005260:Female; D005950:Glucose Solution, Hypertonic / Q000737:chemistry*; D017127:Glycation End Products, Advanced / Q000032:analysis*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007676:Kidney Failure, Chronic / Q000401:mortality* / Q000628:therapy*; D007723:Korea; D008297:Male; D008875:Middle Aged; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000009:adverse effects; D010538:Peritonitis / Q000209:etiology / Q000517:prevention & control; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
D015314:Dialysis Solutions; D005950:Glucose Solution, Hypertonic; D017127:Glycation End Products, Advanced