Chronic Kidney Disease Requiring Chronic Dialysis, End Stage Kidney Disease
Conditions
Keywords
dialysis, peritoneal dialysis
Brief summary
This clinical study is designed to evaluate the theoretical prediction of a lower glucose absorption in optimized automated peritoneal dialysis regimes. Patients will receive both a standard 6 x 2L 1.36% glucose regime or an optimized 7 x 2 L 2.27% glucose + 5 x 2 L 0.1% glucose regime in a crossover fashion.
Detailed description
Automated peritoneal dialysis (APD) is a rapidly growing, home-based kidney replacement therapy promoting patient autonomy, and is associated with lower societal costs compared to hemodialysis. However, in light of the growing number of diabetic patients on PD, the unwanted glucose absorption during APD is problematic. Recent results (Öberg CM, Rippe B, 2017, see references), using a theoretical model of APD, indicate that large reductions in glucose absorption are possible by using specialized so-called optimized bi-modal treatment regimes having UF cycles using a higher glucose concentration (e.g. 2.27% glucose) and Clearance cycles using a low glucose concentration (e.g. 0.1% glucose).
Interventions
PROCEDUREAutomated peritoneal dialysis (APD)
Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.
Sponsors
Universidad de Córdoba
Baxter Healthcare Corporation
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* age between 18 and 75 years; * duration of PD (automated peritoneal dialysis (APD) or continuous ambulatory peritoneal dialysis (CAPD)) \>4 weeks
Exclusion criteria
* severe heart failure (New York Heart Association Functional Classification; NYHA III or IV); * pregnancy; * catheter malfunction or * peritonitis within 3 months prior to the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose absorption | Through study completion, up to 1 year | Amount of glucose absorbed across the peritoneal membrane during the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrafiltration | Through study completion, up to 1 year | Amount of water transported from the circulation to the peritoneal cavity during the treatment |
| Creatinine clearance | Through study completion, up to 1 year | Amount of creatinine transported from the circulation to the peritoneal cavity during the treatment |
| Urea clearance | Through study completion, up to 1 year | Amount of urea transported from the circulation to the peritoneal cavity during the treatment |
| Sodium removal | Through study completion, up to 1 year | Amount of sodium transported from the circulation to the peritoneal cavity during the treatment |
| Incidence of complications | Up to 14 days post-intervention | Complications that are or can be suspected to be related to the study intervention |
Countries
Argentina
Outcome results
None listed