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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Cardio-Renal Syndrome
• Intervention / Treatment: Device: CLS UF

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Division of Nephrology, Heidelberg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Device: CLS UF; 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; One single ultrafiltration session of 10 hours.; 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

Collaborators and Investigators

• Sponsor: Triomed AB
• Investigators: Principal Investigator: Christian Morath, PD Dr. Med, Division of Nephrology, Heidelberg University Hospital, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2016
• Primary Completion (ACTUAL): January 23, 2017
• Study Completion (ACTUAL): January 23, 2017

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (ESTIMATE): May 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Heart Failure; Cardio-Renal Syndrome
• Other Study ID Numbers: CIP Version 1D/2015-12-02; CIV-14-07-012440 (OTHER: Eudamed); Tmed-002 (OTHER: Triomed AB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The Sponsor may choose to publish or present data from this clinical investigation.