A long-term study of a bicarbonate/lactate-based peritoneal dialysis solution--clinical benefits. The Bicarbonate/Lactate Study Group.

OBJECTIVE: A bicarbonate/lactate peritoneal dialysis solution (Bic/Lac) has been developed based on in vitro and ex vivo data showing better preservation of cell function and correction of pain on infusion.
DESIGN: This was a randomized, prospective, controlled, open-label study comparing a new 25 mmol/L bicarbonate/15 mmol/L lactate with a standard 40 mmol/L lactate-buffered peritoneal dialysis solution (Lac) over a 12-month treatment period.
SETTING: 17 European nephrology centers. PATIENTS: 106 (70 Bic/Lac and 36 Lac) well-dialyzed continuous ambulatory peritoneal dialysis (CAPD) patients.
INTERVENTIONS: Dialysis adequacy and peritoneal equilibration test (PET, week -4, months 3, 6, and 12); 24-hour ultrafiltration (week -4, months 1, 3, and 6); blood biochemistry (week -2, day 0, months 1, 2, 3,6, 9, and 12); and a product acceptability questionnaire (months 1 and 6).
RESULTS: 88 patients completed the first 6 months, and 44 the full year. The solutions were shown to be therapeutically equivalent with respect to plasma bicarbonate and peritoneal urea and creatinine clearances. Ultrafiltration in the Bic/Lac group increased significantly from baseline by about 150 mL/day for the whole of the 6-month treatment period (p < 0.05). The biochemistry profile, adverse events, and physical examination (except body weight where there was a statistically significant increase in the Bic/Lac group) results did not differ significantly between the two groups. Reduced pain/discomfort on infusion or an increased sense of well-being was reported by 41% of patients on the Bic/Lac fluid.
CONCLUSIONS: The Bic/Lac solution is safe and effective in correcting uremic acidosis, provides relief of inflow pain/discomfort, and improves ultrafiltration and body weight.

RCT Entities:   Population Interventions Outcomes