Clinical trial NCT04017572: Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study
Official title: Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Kidney Disease
Chronic Kidney Disease Requiring Chronic Dialysis
Keywords: dialysis
peritoneal dialysis
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Universidad de Córdoba
name: Baxter Healthcare Corporation
First posted: 2019-07-12
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Glucose absorption
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Ultrafiltration
timeFrame: Through study completion, up to 1 year
measure: Creatinine clearance
timeFrame: Through study completion, up to 1 year
measure: Urea clearance
timeFrame: Through study completion, up to 1 year
measure: Sodium removal
timeFrame: Through study completion, up to 1 year
measure: Incidence of complications
timeFrame: Up to 14 days post-intervention
Other outcomes:
Locations:
city: Córdoba
country: Argentina
facility: Hospital Privado Centro Médico de Córdoba
Study officials:
affiliation: Lund University
name: Carl M Öberg, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oberg CM, Rippe B. Optimizing Automated Peritoneal Dialysis Using an Extended 3-Pore Model. Kidney Int Rep. 2017 Apr 27;2(5):943-951. doi: 10.1016/j.ekir.2017.04.010. eCollection 2017 Sep.
citation: Bergling K, de Arteaga J, Ledesma F, Oberg CM. Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): study protocol for a randomized controlled crossover trial. Pilot Feasibility Stud. 2020 Jun 10;6:81. doi: 10.1186/s40814-020-00620-2. eCollection 2020.