Clinical trial NCT06390592: Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony
Official title: Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep•Safe Harmony
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Failure
Chronic Kidney Disease
Keywords: Renal replacement therapy
Peritoneal dialysis
Automated peritoneal dialysis
PD cycler
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Alcedis GmbH
First posted: 2024-04-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Interventional, prospective, multi-centric, controlled, randomized, crossover
Primary purpose: TREATMENT

Brief summary: Analysis and comparison of treatments with and without the FlexPoint technology (flexible volume and dwell time management) of the PD cycler sleep•safe harmony

Detailed description: The primary objective of this study are:

* to investigate and compare the clinical performance of standard (default) FlexPoint settings to minimum FlexPoint settings and to the maximum value for permitted peritoneal residual volume of FlexPoint settings of the PD cycler sleep•safe harmony in the treatment of PD patients.
* to assess whether usage of the settings of the therapy option FlexPoint (flexible volume and dwell time management) of the PD cycler sleep•safe harmony that deviate from the system default and from former sleep•safe settings, influences the efficacy of APD treatments as well as the hydration status (by using BCM) of PD patients.

The secondary objectives of this study are:

* Patients´ Quality of Life (QoL)
* Number of alarms
* To investigate the effects on solute removal
* To investigate the tolerability of the FlexPoint therapy options
* Adverse events / SAE

Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/ authorised physician
* Minimum age of 18 years
* CKD patients with indication for renal replacement therapy
* Patients being treated with APD for at least 3 months
* Patients using the sleep•safe harmony PD cycler (version 3.1)
* Fluid status regularly monitored with Body Composition Monitor (BCM)
* Proper functioning catheter
* Intraperitoneal Pressure (IPP) ≤ 18 cm H2O
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Any conditions which could interference with the patient's ability to comply with the study
* Previous participation in the same study
* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
* Patients receiving polyglucose containing PD solution
* Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation
* Patients who suffer from 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
* Participation in an interventional clinical study during the preceding 90 days

Primary outcomes:
measure: Total Kt/V urea
timeFrame: every 2 weeks, during the 6 weeks treatment
Secondary outcomes:
measure: Mean daily ultrafiltration (UF)
timeFrame: every day, during the 6 weeks treatment
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Ramón y Cajal
name: Maite Rivera Gorrín, Dr.
role: PRINCIPAL_INVESTIGATOR
References: