Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-09-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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End Stage Kidney Disease Chronic Kidney Disease Requiring Chronic Dialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard treatment

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

Group Type ACTIVE_COMPARATOR

Automated peritoneal dialysis (APD)

Intervention Type PROCEDURE

Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.

Optimized treatment

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.

Group Type ACTIVE_COMPARATOR

Automated peritoneal dialysis (APD)

Intervention Type PROCEDURE

Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.

Interventions

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Automated peritoneal dialysis (APD)

Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No