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

Status: Terminated

Conditions: Cardio-Renal Syndrome; Heart Failure

Treatments: Device: CLS UF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02772146

CIP Version 1D/2015-12-02

CIV-14-07-012440 (Other Identifier)

Tmed-002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Device: CLS UF

Experimental group

Description:

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.

Treatment:

Device: CLS UF