Clinical Validation of a Continuous flow Peritoneal Dialysis System with Dialysate Regeneratio

Recruiting

• Conditions: End-stage kidney disease; peritoneal dialysis; 10038430

• Registration Number: NL-OMON53288
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

• >=18 years of age.
• Treated with peritoneal dialysis for at least 3 months prior to enrolment
• Well-functioning peritoneal catheter and no peritoneal catheter replacement
for at least a month prior to enrolment.
• Capable of understanding the patient information sheet and informed consent
form (ICF) and give informed consent.
• Willing and able to comply with all study procedures and attend all study
visits.

Exclusion Criteria

• Patients who are unable to provide informed consent.
• Patients who are unable to comply with study procedures.
• Patients who received renal replacement therapy other than conventional PD
less than 8 weeks prior to enrolment.
• Patients who participated in an intervention trial less than 8 weeks prior to
enrolment or are currently participating in an intervention trial which, in the
opinion of the investigator, may adversely affect the safety of the participant
and/or effectiveness of the study. Patients in an observational study without
any interventions or in post-market surveillance do not need to be excluded.
• Patients with PD related infection (exit-site infection, tunnel infection or
peritonitis) less than 8 weeks prior to enrolment.
• Patients with peritoneal catheter dysfunction or mechanical issues less than
one month prior to enrolment.
• Patients who have never used Extraneal® dialysis fluid or have a
contra-indication for Extraneal®:
• Patients with an incompatible PD connection to the device (e.g. Fresenius PD
system)
• Patients with haemoglobin concentrations < 6.2 mmol/L (< 10 g/dL) less than 8
weeks prior to enrolment.
• Patients with hyperkalemia (> 6.0 mmol/L) or hyponatremia (< 130 mmol/L) in
the 8 weeks prior to enrolment.
• Patients with hypocalcemia (plasma total calcium concentration corrected for
albumin <2.20 mmol/L or ionized calcium <1.15 mmol/L) or hypomagnesemia (plasma
magnesium concentration <0.70 mmol/L) in the 8 weeks prior to enrolment.
• Patients with any serious medical condition which in the opinion of the
investigator, may adversely affect the safety of the participant and/or
effectiveness of the study.
• Female patients who are either (planning to become) pregnant within the study
period or breast feeding.
• Patients with a life expectancy <3 months.
• Anticipated living donor kidney transplantation <3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary safety objective will be assessed by describing and examining the<br /><br>incidence of:<br /><br>• serious adverse device effects (SADE) and device deficiencies (DD) that could<br /><br>have led to a serious adverse event (SAE)<br /><br>• critical changes (requiring intervention) in patient*s clinical condition and<br /><br>vital parameters (blood pressure, heart rate, body temperature and oxygen<br /><br>saturation) during treatment.<br /><br>• critical changes (requiring intervention) in hematology and clinical<br /><br>chemistry (i.a. acid base state, electrolytes) pre- vs post-treatment.<br /><br>• critical changes (requiring intervention) in intra-abdominal dialysate volume<br /><br>and intra-abdominal pressure during treatment<br /><br>Evaluation of the events described above will be used to evaluate the<br /><br>short-term safety of WEAKID treatment. No formal statistical hypotheses will be<br /><br>tested.</p><br>