End Stage Renal Disease
Conditions
Keywords
dialysis solutions, renal replacement therapy, peritoneal dialysis, bimodal solution, glucose sparing therapy
Brief summary
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.
Interventions
DRUGbimodal solution
200 mL of 30% glucose infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler
DRUGicodextrin
200 mL of icodextrin infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler
Sponsors
Baxter Healthcare Corporation
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be able to provide informed consent 2. Age greater than 18 years 3. Be stable Automated Peritoneal Dialysis (APD) patients for at least 6 weeks 4. 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 5. Have residual urine volume \<800 ml/24 hours 6. Long dwell must be or patient must tolerate at least an 8-10 hr long dwell.
Exclusion criteria
1. Scheduled Transplant in the next 1 year 2. Life expectancy \< 3 mo (estimated by physician) 3. Participating in other trial that could influence outcome of this trial 4. Known icodextrin allergy 5. Currently using non-Baxter PD solutions 6. Systolic blood pressure \< 90 mm Hg on more than three occasions during a seven day period, despite discontinuation of non-essential anti-hypertensives Supplementary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| net ultrafiltration efficiency in mL/g | Calculated at baseline and at the end of the 6 week intervention period | Ultrafiltration Efficiency (UFE): UFE is defined as the amount of 24 hour net Ultrafiltration (UF) obtained for every gram of carbohydrate absorbed from the dialysis solution. 1. 24-hour net ultrafiltration (in mL) is recorded automatically by the Automated Peritoneal Dialysis (APD) cycler. 2. Carbohydrate absorption is determined by calculating the difference (in grams) between the amount of glucose (measured by lab analysis) in the 24 hr peritoneal effluent, and the amount of glucose in the patient's dialysis prescription. 3. UFE will be calculated in mL/g (ie a divided by b) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour absolute total carbohydrate absorption | Calculated at baseline and at the end of the 6 week intervention period | This will include both glucose and icodextrin absorption. |
| 24-hour urine volume | Calculated at baseline and at the end of the 6 week intervention period | — |
| 24-hour net sodium removal (in both peritoneal effluent and urine) | Calculated at baseline and at the end of the 6 week intervention period | — |
| Volume measures as calculated by bioimpedance analysis | Calculated at baseline and at the end of the 6 week intervention period | — |
| Number of anti-hypertensive agents | Calculated at baseline and at the end of the 6 week intervention period | — |
| Mean and pulse arterial pressure | Calculated at baseline and at the end of the 6 week intervention period | — |
| Renal (urine) solute clearance (Sodium, Urea, Creatinine) | Calculated at baseline and at the end of the 6 week intervention period | — |
| Peritoneal effluent solute clearance (Sodium, Urea, Creatinine) | Calculated at baseline and at the end of the 6 week intervention period | — |
| Weight | Calculated at baseline and at the end of the 6 week intervention period | Used as an indicator of fluid retention |
Countries
Canada
Outcome results
None listed