Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study

End Stage Kidney Disease Clinical Trial

— OptiStAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04017572
• Other study ID #: PCT171447
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2021
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• End Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Argentina	Hospital Privado Centro Médico de Córdoba	Córdoba

Sponsors (3)

Lead Sponsor	Collaborator
Lund University	Baxter Healthcare Corporation, Universidad de Córdoba

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose absorption	Amount of glucose absorbed across the peritoneal membrane during the treatment	Through study completion, up to 1 year
Secondary	Ultrafiltration	Amount of water transported from the circulation to the peritoneal cavity during the treatment	Through study completion, up to 1 year
Secondary	Creatinine clearance	Amount of creatinine transported from the circulation to the peritoneal cavity during the treatment	Through study completion, up to 1 year
Secondary	Urea clearance	Amount of urea transported from the circulation to the peritoneal cavity during the treatment	Through study completion, up to 1 year
Secondary	Sodium removal	Amount of sodium transported from the circulation to the peritoneal cavity during the treatment	Through study completion, up to 1 year
Secondary	Incidence of complications	Complications that are or can be suspected to be related to the study intervention	Up to 14 days post-intervention