Clinical trial NCT02772146: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Cardio-Renal Syndrome
Lead sponsor: Triomed AB
Sponsor class: INDUSTRY
First posted: 2016-05-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ultrafiltrated volume
timeFrame: 10 hours
Secondary outcomes:
measure: 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.
timeFrame: 2-4 weeks
measure: Patient acceptance of the wearable device
timeFrame: 10 hours
measure: Measured glucose levels in the re-circulated PD fluid
timeFrame: 10 hours
measure: Patients acceptability of the re-circulation of PD fluid
timeFrame: 10 hours
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Division of Nephrology, Heidelberg University Hospital
Study officials:
affiliation: Division of Nephrology, Heidelberg University Hospital, Germany
name: Christian Morath, PD Dr. Med
role: PRINCIPAL_INVESTIGATOR
References: