Clinical biocompatibility of a neutral peritoneal dialysis solution with minimal glucose-degradation products--a 1-year randomized control trial.
BACKGROUND
Chronic utilization of a bio-incompatible peritoneal dialysis (PD) solution with acidic pH and a high content of glucose degradation product (GDP) has been implicated as a contributing cause of peritoneal failure. We compared a newly formulated solution of neutral pH and low levels of GDP to a standard PD solution.


METHODS
Fifty new PD patients were randomized to a conventional lactate-buffered fluid (control) and a pH neutral, lactate-buffered, low GDP solution (balance). Patients were followed for 12 months. Serum samples were assayed for C-reactive protein (CRP). PD effluent was collected and assayed for cancer antigen-125 (CA125) and hyaluronan (HA). Clinical end points were the residual renal function and dialysis adequacy indices.


RESULTS
After 52 weeks of treatment, PD fluid CA125 rose from 2.45 +/- 0.96 to 14.30 +/- 2.17 U/ml (P < 0.001), and HA declined from 2.26 +/- 0.60 to 1.45 +/- 0.32 mug/ml (P = 0.07) in the balance group. The balance group had a higher PD fluid CA-125 (14.30 +/- 2.17 vs 7.36 +/- 2.23 U/ml, P = 0.007), lower HA (1.45 +/- 0.32 vs 2.55 +/- 0.32 mug/ml, P = 0.007), and lower serum CRP level (1.77 +/- 0.42 vs 7.73 +/- 2.42 mg/l, P = 0.026) than the control group at 52 weeks. There was no difference in dialysis adequacy indices, ultrafiltration volume, urine output, residual renal function, peritonitis rate or need of hospitalization in 1 year.


CONCLUSIONS
As compared to conventional PD solution, the use of balance, a neutral pH, low GDP solution resulted in a superior profile of PDE mesothelial cell marker and a lower degree of systemic inflammation, and the difference was maintained for 1 year. It remains to be determined whether these effects could result in better long-term clinical outcome.
Szeto
Cheuk-Chun
CC
Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, China. ccszeto@cuhk.edu.hk
Chow
Kai-Ming
KM
Lam
Christopher Wai-Kei
CW
Leung
Chi-Bon
CB
Kwan
Bonnie Ching-Ha
BC
Chung
Kwok-Yi
KY
Law
Man-Ching
MC
Li
Philip Kam-Tao
PK
D015415:Biomarkers / Q000378:metabolism; D018394:CA-125 Antigen / Q000378:metabolism; D015314:Dialysis Solutions / Q000493:pharmacokinetics*; D004727:Endothelium / Q000378:metabolism; D005260:Female; D005500:Follow-Up Studies; D005947:Glucose / Q000493:pharmacokinetics*; D006801:Humans; D006820:Hyaluronic Acid / Q000378:metabolism; D007676:Kidney Failure, Chronic / Q000378:metabolism / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010530:Peritoneal Dialysis / Q000379:methods*; D010537:Peritoneum / Q000378:metabolism; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D018394:CA-125 Antigen; D015314:Dialysis Solutions; D006820:Hyaluronic Acid; D005947:Glucose