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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

Primary Purpose

Heart Failure, Cardio-Renal Syndrome

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

CLS UF

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Division of Nephrology, Heidelberg University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device: CLS UF

Arm Description

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.

Outcomes

Primary Outcome Measures

Ultrafiltrated volume

Ultrafiltrated volume during a 10 hours study session.

Secondary Outcome Measures

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.

Patient acceptance of the wearable device

Subjective opinion of each patient

Measured glucose levels in the re-circulated PD fluid

Patients acceptability of the re-circulation of PD fluid

Any abdominal symptoms of the drain and fill of PD fluid will be recorded.

Full Information

NCT ID

NCT02772146

First Posted

May 9, 2016

Last Updated

March 13, 2017

Sponsor

Triomed AB

1. Study Identification

Unique Protocol Identification Number

NCT02772146

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

May 11, 2016 (Actual)

Primary Completion Date

January 23, 2017 (Actual)

Study Completion Date

January 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Triomed AB

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Cardio-Renal Syndrome

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Device: CLS UF

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

CLS UF

Other Intervention Name(s)

Carry LifeTM System Ultra Filtration

Intervention Description

One single ultrafiltration session of 10 hours.

Primary Outcome Measure Information:

Title

Ultrafiltrated volume

Description

Ultrafiltrated volume during a 10 hours study session.

Time Frame

10 hours

Secondary Outcome Measure Information:

Title

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

Title

Patient acceptance of the wearable device

Description

Subjective opinion of each patient

Time Frame

10 hours

Title

Measured glucose levels in the re-circulated PD fluid

Time Frame

10 hours

Title

Patients acceptability of the re-circulation of PD fluid

Description

Any abdominal symptoms of the drain and fill of PD fluid will be recorded.

Time Frame

10 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Morath, PD Dr. Med

Organizational Affiliation

Division of Nephrology, Heidelberg University Hospital, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Nephrology, Heidelberg University Hospital

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The Sponsor may choose to publish or present data from this clinical investigation.

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