A Clinical Study of the Safety and Efficacy of a Wearable Device (CLS UF) That Delivers Continuous Administration of Glucose to Recirculated Peritoneal Dialysis Fluid for the Purpose of Ultrafiltration in Patients With Congestive Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Triomed AB
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Ultrafiltrated volume
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patient, 18-80 years of age.
- •Prevalent PD patients with CHF with cardio-renal syndrome type II, on stable ultrafiltration, for more than two months, treated with PD based UF according to German national guidelines.
- •Therapy resistance of pharmacologic therapy: resistant hypervolemia with ascites, pleural fluid and pulmonary edema
- •Recurrent hospitalization with cardiac decompensation, ≥ 2 occasions during the last six months
- •Isolated failure of the right heart chamber
- •Treatment based on night time APD therapy combined with a day time long dwell.
- •Obtained written consent to participate in the study.
Exclusion Criteria
- •End stage renal disease requiring dialysis.
- •Malignant disease.
- •On-going infection.
- •Diabetes mellitus.
- •HIV and/or hepatitis positive.
- •Pregnancy.
- •Breastfeeding women.
- •Participation in other clinical trials within one month before inclusion.
- •Abdominal hernia.
- •Cardiac diseases other than left ventricular heart failure, biventricular heart failure or isolated right heart chamber failure, with volume overload.
- •Any immune deficiency.
Outcomes
Primary Outcomes
Ultrafiltrated volume
Time Frame: 10 hours
Ultrafiltrated volume during a 10 hours study session.
Secondary Outcomes
- 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.(2-4 weeks)
- Measured glucose levels in the re-circulated PD fluid(10 hours)
- Patient acceptance of the wearable device(10 hours)
- Patients acceptability of the re-circulation of PD fluid(10 hours)