Use of a Bimodal Solution for Peritoneal Dialysis

Lawson Health Research Institute

Status and phase

Completed

Phase 2

Conditions

End Stage Renal Disease

Treatments

Drug: bimodal solution

Drug: icodextrin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01242904

R-10-460

17193 (Other Identifier)

Details and patient eligibility

About

Peritoneal dialysis (PD) is the method of renal replacement therapy used by close to 200,000 end stage renal disease patients worldwide to help replace the functions that are no longer performed by their kidneys. An important advantage of PD is it offers an alternative to hemodialysis that can be safely performed by patients in their own homes. In PD, the peritoneal membrane that lines the abdomen acts as a dialyzer that allows the transfer of solutes and water between the membrane capillaries and a dialysis solution that is infused into the peritoneal cavity. PD dialysis solutions typically require high concentrations of glucose to adequately perform these functions. Over time the continued exposure of the peritoneal membrane to high concentrations of glucose can permanently damage the membrane. Icodextrin is a polyglucose molecule that has been developed for use in PD solutions that does not harm the peritoneal membrane. However, its use can lead to inadequate fluid removal. Recent research has focused on finding a PD solution, or combination of solutions, that will maximize the removal of toxic substances and metabolites while maintaining regulation of fluid and electrolyte balance in the body. A bimodal solution that combines glucose and icodextrin has been shown in observational studies to be effective and safe. The investigators propose a randomized, controlled, blinded study that will determine the effectiveness and safety of this bimodal fluid in a Canadian PD population. The investigators hypothesize that the use of the bimodal solution during the long (day) dwell will lead to an improvement in 24 hour ultrafiltration efficiency as compared to usual care using icodextrin for the long dwell.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Be able to provide informed consent
Age greater than 18 years
Be stable Automated Peritoneal Dialysis (APD) patients for at least 6 weeks
Be APD patients who;
1. Can be managed with an icodextrin long dwell AND
2. Will use 4.25% and/or a 2.5% solution for at least one exchange overnight in at least 5 out of 7 days
Have residual urine volume <800 ml/24 hours
Long dwell must be or patient must tolerate at least an 8-10 hr long dwell.

Exclusion criteria

Scheduled Transplant in the next 1 year
Life expectancy < 3 mo (estimated by physician)
Participating in other trial that could influence outcome of this trial
Known icodextrin allergy
Currently using non-Baxter PD solutions
Systolic blood pressure < 90 mm Hg on more than three occasions during a seven day period, despite discontinuation of non-essential anti-hypertensives

Supplementary Exclusion Criteria (post Run-in phase):

Unsuccessfully completed 1 week run-in phase. Defined as:

Not using bimodal solution on 7 consecutive days during the run-in
Not tolerating the increased UF anticipated with the bimodal solution. Tolerating defined as:

i) Blood pressure drop below 90/50 on more than three occasions during a seven day period that cannot be corrected by reducing anti-hypertensives or other simple measures ii) Intolerable feeling of fullness with the bimodal solution iii) Allergic reaction (although all patients have already been exposed to icodextrin)