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 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.

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

Conditions
-----------------
Heart Failure, Cardio-Renal Syndrome

Intervention / Treatment
-----------------
* Device: CLS UF


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: CLS UF<br>The purpose of CLS UF is ultrafiltration and drain of excess fluid in patients with congestive heart failure. The function of the device is to extra corporeally recirculate profiled glucose based PD fluid in a system and maintain glucose levels by adding extra glucose, to an adjustable and constant level, in order to maintain a stable ultrafiltration. | Device: CLS UF<br>* One single ultrafiltration session of 10 hours.<br>* Other names: Carry LifeTM System Ultra Filtration;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrafiltrated volume | Ultrafiltrated volume during a 10 hours study session. | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Patient acceptance of the wearable device | Subjective opinion of each patient | 10 hours | 
| Measured glucose levels in the re-circulated PD fluid |  | 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. | 10 hours |