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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02772146
• Other study ID #: CIP Version 1D/2015-12-02
• Secondary ID: CIV-14-07-012440
• Status: Terminated
• Phase: N/A
• First received: May 9, 2016
• Last updated: March 13, 2017
• Start date: May 11, 2016
• Est. completion date: January 23, 2017

Study information

• Verified date: February 2017
• Source: Triomed AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 23, 2017
• Est. primary completion date: January 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardio-Renal Syndrome
• Heart Failure

Intervention

Device:
• CLS UF
One single ultrafiltration session of 10 hours.

Locations

Country	Name	City	State
Germany	Division of Nephrology, Heidelberg University Hospital	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Triomed AB

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrafiltrated volume	Ultrafiltrated volume during a 10 hours study session.	10 hours
Secondary	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
Secondary	Patient acceptance of the wearable device	Subjective opinion of each patient	10 hours
Secondary	Measured glucose levels in the re-circulated PD fluid		10 hours
Secondary	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