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Not yet recruiting NCT06390592

Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony

No phase Interventional Renal Failure Chronic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD cycler.
Who it may be relevant to
Registry conditions: Renal Failure, Chronic Kidney Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Performance of the Therapy Option FlexPoint (Flexible Volume and Dwell Time Management) of the PD Cycler Sleep•Safe Harmony

Overview

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

Interventions

  • Device 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)

Primary outcome measures

  • Total Kt/V urea [Time frame: every 2 weeks, during the 6 weeks treatment]
Secondary outcome measures (1)
  • Mean daily ultrafiltration (UF) [Time frame: every day, during the 6 weeks treatment]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06390592 · PD-SSH-01-INT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗