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

• ClinicalTrials.gov Identifier: NCT04017572
• Recruitment Status: Completed
• First Posted: July 12, 2019
• Last Update Posted: February 12, 2021
• Sponsor: Lund University
• Collaborators: Universidad de Córdoba; Baxter Healthcare Corporation
• Information provided by (Responsible Party): Lund University

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)	Not Applicable

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 (Clinical Trial)
• 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: June 1, 2019
• Actual Primary Completion Date: September 30, 2020
• Actual Study Completion Date: September 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Argentina

Hospital Privado Centro Médico de Córdoba

Córdoba, Argentina, 5016

Sponsors and Collaborators

Lund University

Universidad de Córdoba

Baxter Healthcare Corporation

Investigators

• Principal Investigator: Carl M Öberg, M.D., Ph.D.; Lund University

More Information

Publications:

Öberg 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bergling K, de Arteaga J, Ledesma F, Öberg 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.

• Responsible Party: Lund University
• ClinicalTrials.gov Identifier: NCT04017572
• Other Study ID Numbers: PCT171447
• First Posted: July 12, 2019
• Last Update Posted: February 12, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lund University:

dialysis; peritoneal dialysis

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Urologic Diseases; Renal Insufficiency