Optimized vs. Standard Automated Peritoneal Dialysis Regimens Study

Not Applicable

Completed

• Conditions: End Stage Kidney Disease; Chronic Kidney Disease Requiring Chronic Dialysis
• Interventions: Procedure: Automated peritoneal dialysis (APD)

• Registration Number: NCT04017572
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2019-07-04
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard treatment	Automated peritoneal dialysis (APD)	APD-treatment with a net volume of 12 L 1.36 % anhydrous glucose peritoneal dialysis solution during 540 minutes.
Optimized treatment	Automated peritoneal dialysis (APD)	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.

Primary Outcome Measures

Name	Time	Method
Glucose absorption	Through study completion, up to 1 year	Amount of glucose absorbed across the peritoneal membrane during the treatment

Secondary Outcome Measures

Name	Time	Method
Urea clearance	Through study completion, up to 1 year	Amount of urea transported from the circulation to the peritoneal cavity during the treatment
Ultrafiltration	Through study completion, up to 1 year	Amount of water transported from the circulation to the peritoneal cavity during the treatment
Creatinine clearance	Through study completion, up to 1 year	Amount of creatinine transported from the circulation to the peritoneal cavity during the treatment
Sodium removal	Through study completion, up to 1 year	Amount of sodium transported from the circulation to the peritoneal cavity during the treatment
Incidence of complications	Up to 14 days post-intervention	Complications that are or can be suspected to be related to the study intervention

Trial Locations

Locations (1)

Hospital Privado Centro Médico de Córdoba; 🇦🇷 Córdoba, Argentina