A Randomized Controlled Trial of a Bicarbonate and a Bicarbonate/Lactate-Containing Dialysis Solution in Capd

Abstract

Objective

To evaluate the safety and efficacy of bicarbonate and bicarbonate/lactate-based PD fluids.

Design

A randomly allocated prospective controlled trial lasting eight weeks.

Setting

Five renal units in Europe.

Patients

Individuals who have been treated by CAPD for at least 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 other serious illness are excluded. Forty-seven individuals have entered the study so far.

Interventions

Patients are randomly allocated to three groups. Group 1 receive 40 mmol/L lactate dialysate, Group 2 are given 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 events 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 period. 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.