Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony
NCT ID: NCT06390592
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
24 participants
INTERVENTIONAL
2025-12-31
2026-12-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Peritoneal dialysis (PD)
During the clinical phase, patients are treated continuously with the PD cycler sleep•safe harmony.
The total duration of the clinical phase is six weeks and is divided into 3 Phases à 2 weeks (Clinical phase I, II, and III) which only differ in the FlexPoint settings.
According to their randomization the patients are treated with Treatment A, B or C in a different order:
* standard (default) FlexPoint settings (Treatment A)
* minimum value FlexPoint settings (Treatment B)
* maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)
PD cycler
Patients are treated continuously during Peritoneal dialysis with the PD cycler sleep•safe harmony with different FlexPoint settings.
According to their randomization the patients are treated with Treatment A, B or C in a different order:
* standard (default) FlexPoint settings (Treatment A)
* minimum value FlexPoint settings (Treatment B)
* maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)
Interventions
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PD cycler
Patients are treated continuously during Peritoneal dialysis with the PD cycler sleep•safe harmony with different FlexPoint settings.
According to their randomization the patients are treated with Treatment A, B or C in a different order:
* standard (default) FlexPoint settings (Treatment A)
* minimum value FlexPoint settings (Treatment B)
* maximum value for permitted peritoneal residual volume (50%) of FlexPoint settings (Treatment C)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Alcedis GmbH
INDUSTRY
Fresenius Medical Care Deutschland GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Maite Rivera Gorrín, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Ramón y Cajal
Central Contacts
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Other Identifiers
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PD-SSH-01-INT
Identifier Type: -
Identifier Source: org_study_id
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