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Completed

NCT Number: NCT04017572

Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study

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.

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Key information

Conditions

End Stage Kidney Disease Chronic Disease Chronic Kidney Disease Requiring Chronic Dialysis Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Privado Centro Médico de Córdoba

Córdoba, 5016, Argentina

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Automated peritoneal dialysis (APD)

Procedure

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

Primary outcomes

  1. Glucose absorption

    Time frame: Through study completion, up to 1 year

    Amount of glucose absorbed across the peritoneal membrane during the treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Baxter Healthcare Corporation
  • Universidad de Córdoba

Registry information

Official study title

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

Acronym: OptiStAR

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2019
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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