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Clinical Trials/NCT02772146
NCT02772146TerminatedNot Applicable

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

Triomed AB2 sites in 1 country2 target enrollmentStarted: May 11, 2016Last updated:
Conditions

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)

Investigators

Sponsor
Triomed AB
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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