Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study (OptiStAR)

Lund University

Status: Completed

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis; End Stage Kidney Disease

Treatments: Procedure: Automated peritoneal dialysis (APD)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04017572

PCT171447

Details and patient eligibility

About

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.

Full 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).

Enrollment: 21 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Standard treatment

Active Comparator group

Description:

APD-treatment with a net volume of 12 L 1.36 % anhydrous glucose peritoneal dialysis solution during 540 minutes.

Treatment:

Procedure: Automated peritoneal dialysis (APD)

Optimized treatment

Active Comparator group

Description:

APD-treatment with a net volume of 14 L 2.27 % anhydrous glucose peritoneal dialysis solution during 280 minutes followed by a net volume of 10 L 0.1 % glucose dialysis fluid during 200 minutes.

Treatment:

Procedure: Automated peritoneal dialysis (APD)