Clinical trial NCT06443021: Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Failure
Chronic Kidney Diseases
Keywords: Renal replacement therapy
Peritoneal dialysis
Automated peritoneal dialysis
PD cycler
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Winicker Norimed GmbH
First posted: 2024-06-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Prospective, multi-centric, interventional
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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")

Primary outcomes:
measure: Ultrafiltration volume (UFV)
timeFrame: every day during the 11 weeks treatment
Secondary outcomes:
measure: Fluid status
timeFrame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
measure: 24 h batch collection
timeFrame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
measure: 24 h batch collection
timeFrame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
measure: 24 h batch collection
timeFrame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
measure: 24 h batch collection
timeFrame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
measure: 24 h batch collection
timeFrame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
measure: 24 h batch collection
timeFrame: At study start, and then after 3 weeks, 4 weeks and 5 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Son Espases
name: Isabel Garcia Méndez, Dr.
role: PRINCIPAL_INVESTIGATOR
References: