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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04017572
Other study ID # PCT171447
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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