Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02772146
Recruitment Status : Terminated (After 2 patients it was concluded that a large change in exclusion criteria and study design was needed to obtain the ojective for the study)
First Posted : May 13, 2016
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Triomed AB

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.

Condition or disease Intervention/treatment Phase
Heart Failure Cardio-Renal Syndrome Device: CLS UF Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : May 11, 2016
Actual Primary Completion Date : January 23, 2017
Actual Study Completion Date : January 23, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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 Name: Carry LifeTM System Ultra Filtration




Primary Outcome Measures :
  1. Ultrafiltrated volume [ Time Frame: 10 hours ]
    Ultrafiltrated volume during a 10 hours study session.


Secondary Outcome Measures :
  1. 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 ]
  2. Patient acceptance of the wearable device [ Time Frame: 10 hours ]
    Subjective opinion of each patient

  3. Measured glucose levels in the re-circulated PD fluid [ Time Frame: 10 hours ]
  4. Patients acceptability of the re-circulation of PD fluid [ Time Frame: 10 hours ]
    Any abdominal symptoms of the drain and fill of PD fluid will be recorded.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772146


Locations
Layout table for location information
Germany
Division of Nephrology, Heidelberg University Hospital
Heidelberg, Germany, 69120
Sponsors and Collaborators
Triomed AB
Investigators
Layout table for investigator information
Principal Investigator: Christian Morath, PD Dr. Med Division of Nephrology, Heidelberg University Hospital, Germany
Layout table for additonal information
Responsible Party: Triomed AB
ClinicalTrials.gov Identifier: NCT02772146    
Other Study ID Numbers: CIP Version 1D/2015-12-02
CIV-14-07-012440 ( Other Identifier: Eudamed )
Tmed-002 ( Other Identifier: Triomed AB )
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The Sponsor may choose to publish or present data from this clinical investigation.
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardio-Renal Syndrome
Heart Failure
Heart Diseases
Cardiovascular Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases