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

NCT02772146 | Terminated

• 3 other identifiers: CIP Version 1D/2015-12-02CIV-14-07-012440Tmed-002
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Cardio-Renal Syndrome

Outcome Measures

Primary Outcomes (1)

• Ultrafiltrated volume

  Ultrafiltrated volume during a 10 hours study session.

  10 hours

Secondary Outcomes (4)

• 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

  10 hours

• Measured glucose levels in the re-circulated PD fluid

  10 hours

• Patients acceptability of the re-circulation of PD fluid

  10 hours

Study Arms (1)

Device: CLS UF

EXPERIMENTAL

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

Interventions

CLS UF DEVICE

One single ultrafiltration session of 10 hours.

Also known as: Carry LifeTM System Ultra Filtration

Device: CLS UF

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• End stage renal disease requiring dialysis.
• Malignant disease.
• On-going infection.
• Diabetes mellitus.
• HIV and/or hepatitis positive.
• Pregnancy.
• Breastfeeding women.
• 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.

Sponsors & Collaborators

• Triomed AB: lead

Study Sites (1)

Division of Nephrology, Heidelberg University Hospital

Heidelberg, Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Heart Failure; Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Christian Morath, PD Dr. Med

  Division of Nephrology, Heidelberg University Hospital, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 13, 2016
• Study Start: May 11, 2016
• Primary Completion: January 23, 2017
• Study Completion: January 23, 2017
• Last Updated: March 14, 2017

Record last verified: 2017-02

Locations

DE (1)