A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient will be studied during a single treatment session of ten hours. The device will be connected to an existing, standard PD catheter that the patient will be using routinely prior to the study (i.e. a peritoneal dialysis catheter will not be specifically inserted for the study). The patient will be hospitalized for observation during the test day and during the night following the study session. Ultrafiltration volume, dialysate glucose concentrations, blood glucose concentrations as well the patient's acceptability and tolerance of the wearable device will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
2
One single ultrafiltration session of 10 hours.
Division of Nephrology, Heidelberg University Hospital
Heidelberg, Heidelberg, Germany
Ultrafiltrated volume
Ultrafiltrated volume during a 10 hours study session.
Time frame: 10 hours
Any Adverse Event (AE), Serious Adverse Event (SAE), Adverse Device Effect (ADE) or Serious Adverse Device Effect (SADE) occurring during the study session and until the follow-up visit.
Time frame: 2-4 weeks
Patient acceptance of the wearable device
Subjective opinion of each patient
Time frame: 10 hours
Measured glucose levels in the re-circulated PD fluid
Time frame: 10 hours
Patients acceptability of the re-circulation of PD fluid
Any abdominal symptoms of the drain and fill of PD fluid will be recorded.
Time frame: 10 hours
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