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

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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Kidney Disease; Chronic Kidney Disease Requiring Chronic Dialysis
• Intervention / Treatment: Procedure: Automated peritoneal dialysis (APD)

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina, 5016
    • Hospital Privado Centro Medico de Cordoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose absorption	Amount of glucose absorbed across the peritoneal membrane during the treatment	Through study completion, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrafiltration	Amount of water transported from the circulation to the peritoneal cavity during the treatment	Through study completion, up to 1 year
Creatinine clearance	Amount of creatinine transported from the circulation to the peritoneal cavity during the treatment	Through study completion, up to 1 year
Urea clearance	Amount of urea transported from the circulation to the peritoneal cavity during the treatment	Through study completion, up to 1 year
Sodium removal	Amount of sodium transported from the circulation to the peritoneal cavity during the treatment	Through study completion, up to 1 year
Incidence of complications	Complications that are or can be suspected to be related to the study intervention	Up to 14 days post-intervention

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Baxter Healthcare Corporation; Universidad de Córdoba
• Investigators: Principal Investigator: Carl M Öberg, M.D., Ph.D., Lund University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: dialysis; peritoneal dialysis
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: PCT171447

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No