A Randomized Cross-over Study Comparing the Performance of HD Integra™ Central Concentrate System Versus Pre-produced Concentrate in Hemodialysis

Overview

Journal BMC Nephrol

Publisher Biomed Central

Specialty Nephrology

Date 2017 Apr 5

PMID 28372556

Authors

K Fauziah

K W Go

A Ghazali

M Zaki

T O Lim

Affiliations

Soon will be listed here.

Abstract

Background: Pre-produced bicarbonate concentrates (PPC) are still widely used in developing countries despite its cost and risk but Central Concentrate System (CCS) is lacking in data to support its wider adoption.

Methods: We conducted an 8-week randomized crossover study on 16 Hemodialysis machines to compare CCS versus PPC. Performance is assessed by solute concentrations while safety is assessed by microbial count, endotoxin level and adverse event reporting.

Results: Microbial counts and endotoxin levels were monitored on 48 occasions during the 8-week study for the CCS arm of the study. The levels were all below the action limit during the study. No patient reported any adverse events. Dialysate Sodium, Chloride and Bicarbonate concentrations were measured on a total of 128 occasions for each arm of the study. The relative deviations of Sodium, Chloride and Bicarbonate concentration were within ±5% of their nominal values for both. The 95% Confidence Intervals for the ratio of the mean solute concentrations on the CCS to PPC lie within the tolerance limit of ±5%.

Conclusion: Modern CCS is bacteriologically safe and its performance statistically equivalent to PPC.

References

Stragier A, Wenderickx D . Bacterial growth prevention in liquid bicarbonate concentrate. EDTNA ERCA J. 1999; 24(3):40-2, 44. View

De Vos J, Marzougui H, Hombrouckx R . Automated on-line bicarbonate concentrate production: microbiological, chemical and economic benefits. EDTNA ERCA J. 1996; 22(4):5-6. View

Rehmert N, Bocker T, Raidt H, Langer K, Graefe H . A new central supply system as alternative source for bicarbonate dialysate. Int J Artif Organs. 1992; 15(6):339-42. View

Ebben J, Hirsch D, Luehmann D, Collins A, Keshaviah P . Microbiologic contamination of liquid bicarbonate concentrate for hemodialysis. ASAIO Trans. 1987; 33(3):269-73. View

Ledebo I . On-line preparation of solutions for dialysis: practical aspects versus safety and regulations. J Am Soc Nephrol. 2002; 13 Suppl 1:S78-83. View

Canaud B, Bosc J, Leray H, Morena M, Stec F . Microbiologic purity of dialysate: rationale and technical aspects. Blood Purif. 2000; 18(3):200-13. DOI: 10.1159/000014419. View

Oettinger C, Oliver J . An economical new process for incenter bicarbonate dialysate production: comparison with acetate in a large dialysis population. Artif Organs. 1989; 13(5):432-7. DOI: 10.1111/j.1525-1594.1989.tb01553.x. View

Ruderman M, Yungbluth M, Del Greco F, Krumlovsky F, Beske R . Preparation of bacteriologically safe bicarbonate concentrate for hemodialysis. ASAIO Trans. 1988; 34(3):606-7. View

Alter M, Favero M, Moyer L, Bland L . National surveillance of dialysis-associated diseases in the United States, 1989. ASAIO Trans. 1991; 37(2):97-109. View

10.

Friedman E, Lundin 3rd A . Dialysate delivery: historical, theoretical, and practical aspect. Kidney Int Suppl. 1980; 10:S33-43. View

11.

Bland L, Ridgeway M, Aguero S, Carson L, Favero M . Potential bacteriologic and endotoxin hazards associated with liquid bicarbonate concentrate. ASAIO Trans. 1987; 33(3):542-5. View

12.

Beige J, Lutter S, Martus P . On-site production of a dialysis bath from dry salts. Results of solute concentration control by routine clinical chemistry. Clin Kidney J. 2012; 5(3):207-211. PMC: 3401082. DOI: 10.1093/ckj/sfs043. View

13.

Han S, Yi J, Kim H . Current status of central concentrate delivery system for hemodialysis in Korea. Blood Purif. 2009; 27 Suppl 1:70-3. DOI: 10.1159/000213501. View

14.

GRIMSRUD L, Cole J, Lehman G, BABB A, Scribner B . A central system for the continuous preparation and distribution of hemodialysis fluid. Trans Am Soc Artif Intern Organs. 1964; 10:107-9. View