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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02772146
• Date of registration: 09/05/2016
• Prospective Registration: Yes
• Primary sponsor: Triomed AB
• Public 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
• Scientific 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
• Date of first enrolment: May 11, 2016
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02772146
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Christian Morath, PD Dr. Med
• Affiliation: Division of Nephrology, Heidelberg University Hospital, Germany

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Heart Failure

Cardio-Renal Syndrome

Intervention(s)

Device: CLS UF

Primary Outcome(s)

Ultrafiltrated volume [Time Frame: 10 hours]

Secondary Outcome(s)

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. [Time Frame: 2-4 weeks]

Measured glucose levels in the re-circulated PD fluid [Time Frame: 10 hours]

Patient acceptance of the wearable device [Time Frame: 10 hours]

Patients acceptability of the re-circulation of PD fluid [Time Frame: 10 hours]

Secondary ID(s)

Tmed-002

CIP Version 1D/2015-12-02

CIV-14-07-012440

Source(s) of Monetary Support

Please refer to primary and secondary sponsors