A RANDOMIZED CONTROLLED TRIAL OF A BICARBONATE-CONTAINING AND A BICARBONATE LACTATE-CONTAINING DIALYSIS SOLUTION IN CAPD/

Objective: To evaluate the safety and efficacy of bicarbonate- and bic arbonate/lactate-based PD fluids. Design: A randomly allocated prospec tive controlled trial lasting eight weeks.Setting: Five renal units in Europe. Patients: Individuals who have been treated by CAPD for at le ast three months and who have had at least one month's therapy with 40 mmol/L lactate PD fluid. Those with recent infection, diabetes or oth er serious illness are excluded. Forty-seven individuals have entered the study so far. Interventions: Patients are randomly allocated to th ree groups. Group 1 receive 40 mmol/L lactate dialysate, Group 2 are g iven 38 mmol/L bicarbonate fluid and Group 3 are tested with a 25 mmol /L bicarbonate and 15 mmol/L lactate dialysate. Outcome measures: The primary outcome measure is the plasma bicarbonate level. Adverse event s and ease of use of the two-chambered bags used by Groups 2 and 3 are also being assessed. Results: To date, plasma bicarbonate levels have been the same in all treatment groups up to the end of the trial peri od. There are no differences in serum lactate levels. No side effects are attributable to the test fluids. The patients have managed the two -chambered bags successfully. Conclusion: This trial is still ongoing, but to date, neutral bicarbonate based fluids have been as effective as lactate dialysate in treating uremic acidosis.