Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients

Chronic Kidney Diseases Clinical Trial

— pPD  

Official title:

Investigation of the Influence of Variable Fill Volume, Dwell Duration and Dialysis Fluid Glucose Composition on Measured Ultrafiltration Volume (UFV) in Automated Peritoneal Dialysis (APD) Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06443021
• Other study ID #: PD-pPD-01-ESP
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: Manuela Stauss-Grabo, Dr.
• Phone: +49 1525 469 1929
• Email: Manuela.Stauss-Grabo1[@]freseniusmedicalcare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy. While building on the ideas of the past, the concept is augmented by leveraging additional diagnostic technologies and digital data analytics methodologies.

Description:

The primary objective of this study is:

• UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes

The secondary objectives of this study are:

• Mean daily UFV

• Defined laboratory parameter like urea, creatinine, glucose, sodium determined in blood and dialysate during the extended PET (in dialysate additionally determination: phosphate, albumin removal)

• Treatment parameter: performed treatment duration and volume

• Fluid status measured by Body Composition Monitor (BCM)

• Manual IPP determination during the extended PET: At the first half of the dwell (during the first hour) for every 20 min and during the second half after 2h, 3h and 4h dwell time

• Residual renal function (RRF): renal urea and creatinine clearance, 24h urine output, Glomerular filtration rate (GFR)

• Extended PET

• 24 h batch collection (including e.g. total peritoneal clearance)

• Analysis of daily dietetic fluid intake, weight and further parameters documented by the patient in a patient diary

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent signed and dated by study patient and investigator/ authorized physician

• Patients between 18-65 of age

• Chronic kidney disease (CKD) patients being treated with nocturnal APD for at least 3 months

• Ability to understand the nature and requirements of the study

• Total Kt/V = 1.7 (counting from recruitment of the patient the measurement should not be older than 3 months)

• APD patients using sleep•safe PD-cycler or sleep•safe harmony PD-cycler with an IPP = 18 cm H2O for the fill volume of 120%

Exclusion Criteria:

• Any condition which could interfere with the patient's ability to comply with the study

• Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)

• Patients who have been subject to peritonitis/ exit site infection during the last 4 weeks

• Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period

• Life expectancy < 3 months

• Patients suffering from uncontrolled/ not well adjustable diabetes

• Recent history of drain related problems, catheter malfunction, or frequent alarms during treatment

• Patients with uncontrolled hypertension and/ or previous history of vascular instability during PD

• Patients treated with intermittent APD

• Participation in an interventional clinical study during the preceding 30 days

• Previous participation in the same study

• APD patients having dwell exchanges throughout the day ("day dwell")

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Failure
• Renal Insufficiency, Chronic

Intervention

Device:
• PD cycler
After a training phase and a run-in period of up to 6 weeks, depending on the PD cycler used prior to the study, the interventional phase will be initiated. Study phase A, variation of dwell duration: Duration of short cycles (cycle 1 and 2) 30 min, 60 min, 90 min, 120 min (and 150 min depending on the patient´s constitution and at the discretion of the treating physician) Study phase B, variation of dialysis fluid glucose composition: 1st cycle: 1.5% glucose concentration, 2nd cycle: 2.3% glucose concentration, 3rd cycle: 1.5% glucose concentration, 4th cycle: 2.3% glucose concentration; all following cycles to be applied as prescribed by the treating physician. Study phase C, variation of fill volume: 60% fill volume, 80% fill volume, 100% fill volume and 120% fill volume. (Volume of 120% will only be applied in case the patient tolerates these volumes according to the IPP.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	Winicker Norimed GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrafiltration volume (UFV)	UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes.	every day during the 11 weeks treatment
Secondary	Fluid status	Fluid status measured by Body Composition Monitor (BCM)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
Secondary	24 h batch collection	RRF (24 h urine output)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
Secondary	24 h batch collection	RRF (GFR)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
Secondary	24 h batch collection	RRF (renal creatinine clearance)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
Secondary	24 h batch collection	RRF (renal urea clearance)	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
Secondary	24 h batch collection	Peritoneal urea clearance	At study start, and then after 3 weeks, 4 weeks and 5 weeks.
Secondary	24 h batch collection	Peritoneal creatinine clearance	At study start, and then after 3 weeks, 4 weeks and 5 weeks.