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

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ClinicalTrials.gov Identifier: NCT04017572
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborators:
Universidad de Córdoba
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Carl M. Öberg, Lund University

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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.




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



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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 and
  • daily urine output >500 ml.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017572


Contacts
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Contact: Carl M Öberg, M.D., Ph.D. +46-709-221947 Carl.Oberg@med.lu.se
Contact: Javier de Arteaga, M.D., Ph.D. +54-351-4688230 javierdearteaga@gmail.com

Locations
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Argentina
Hospital Privado Centro Médico de Córdoba Recruiting
Córdoba, Argentina, 5016
Contact: Javier de Arteaga, M.D., Ph.D.    +54 351 4688230    javierdearteaga@gmail.com   
Sub-Investigator: Javier de Arteaga, M.D., Ph.D.         
Principal Investigator: Carl M Öberg, M.D., Ph.D.         
Sponsors and Collaborators
Carl M. Öberg
Universidad de Córdoba
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Carl M Öberg, M.D., Ph.D. Lund University

Publications:
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Responsible Party: Carl M. Öberg, Principal Investigator, Lund University
ClinicalTrials.gov Identifier: NCT04017572     History of Changes
Other Study ID Numbers: PCT171447
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Carl M. Öberg, Lund University:
dialysis
peritoneal dialysis

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions