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

Primary Purpose

End Stage Kidney Disease, Chronic Kidney Disease Requiring Chronic Dialysis

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Automated peritoneal dialysis (APD)
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Kidney Disease focused on measuring dialysis, peritoneal dialysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Privado Centro Médico de Córdoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard treatment

Optimized treatment

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Glucose absorption
Amount of glucose absorbed across the peritoneal membrane during the treatment

Secondary Outcome Measures

Ultrafiltration
Amount of water transported from the circulation to the peritoneal cavity during the treatment
Creatinine clearance
Amount of creatinine transported from the circulation to the peritoneal cavity during the treatment
Urea clearance
Amount of urea transported from the circulation to the peritoneal cavity during the treatment
Sodium removal
Amount of sodium transported from the circulation to the peritoneal cavity during the treatment
Incidence of complications
Complications that are or can be suspected to be related to the study intervention

Full Information

First Posted
July 4, 2019
Last Updated
February 10, 2021
Sponsor
Lund University
Collaborators
Universidad de Córdoba, Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04017572
Brief Title
Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study
Acronym
OptiStAR
Official Title
Optimized vs. Standard Automated Peritoneal Dialysis Regimens (OptiStAR): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
Collaborators
Universidad de Córdoba, Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Kidney Disease, Chronic Kidney Disease Requiring Chronic Dialysis
Keywords
dialysis, peritoneal dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
APD-treatment with a net volume of 12 L 1.36 % anhydrous glucose peritoneal dialysis solution during 540 minutes.
Arm Title
Optimized treatment
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Automated peritoneal dialysis (APD)
Intervention Description
Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.
Primary Outcome Measure Information:
Title
Glucose absorption
Description
Amount of glucose absorbed across the peritoneal membrane during the treatment
Time Frame
Through study completion, up to 1 year
Secondary Outcome Measure Information:
Title
Ultrafiltration
Description
Amount of water transported from the circulation to the peritoneal cavity during the treatment
Time Frame
Through study completion, up to 1 year
Title
Creatinine clearance
Description
Amount of creatinine transported from the circulation to the peritoneal cavity during the treatment
Time Frame
Through study completion, up to 1 year
Title
Urea clearance
Description
Amount of urea transported from the circulation to the peritoneal cavity during the treatment
Time Frame
Through study completion, up to 1 year
Title
Sodium removal
Description
Amount of sodium transported from the circulation to the peritoneal cavity during the treatment
Time Frame
Through study completion, up to 1 year
Title
Incidence of complications
Description
Complications that are or can be suspected to be related to the study intervention
Time Frame
Up to 14 days post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl M Öberg, M.D., Ph.D.
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Privado Centro Médico de Córdoba
City
Córdoba
ZIP/Postal Code
5016
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29270500
Citation
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.
Results Reference
background
PubMed Identifier
32528722
Citation
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.
Results Reference
derived

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Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study

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