OptiStAR: Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study

Sponsor

Lund University (Other)

Overall Status

Completed

CT.gov ID

NCT04017572

Collaborator

Universidad de Córdoba (Other), Baxter Healthcare Corporation (Industry)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
End Stage Kidney Disease Chronic Kidney Disease Requiring Chronic Dialysis	Procedure: Automated peritoneal dialysis (APD)	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): A Randomized Controlled Trial

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Sep 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard treatment APD-treatment with a net volume of 12 L 1.36 % anhydrous glucose peritoneal dialysis solution during 540 minutes.	Procedure: Automated peritoneal dialysis (APD) Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.
Active Comparator: 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.	Procedure: Automated peritoneal dialysis (APD) Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.

Arm

Intervention/Treatment

Active Comparator: Standard treatment

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

Procedure: Automated peritoneal dialysis (APD)

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

Active Comparator: 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.

Procedure: Automated peritoneal dialysis (APD)

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

Outcome Measures

Primary Outcome Measures

Glucose absorption [Through study completion, up to 1 year]
Amount of glucose absorbed across the peritoneal membrane during the treatment

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.