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
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- Ultrafiltrated volume [10 hours]
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. [2-4 weeks]
- Patient acceptance of the wearable device [10 hours]
Subjective opinion of each patient
- Measured glucose levels in the re-circulated PD fluid [10 hours]
- Patients acceptability of the re-circulation of PD fluid [10 hours]
Any abdominal symptoms of the drain and fill of PD fluid will be recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patient, 18-80 years of age.
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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.
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Therapy resistance of pharmacologic therapy: resistant hypervolemia with ascites, pleural fluid and pulmonary edema
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Recurrent hospitalization with cardiac decompensation, ≥ 2 occasions during the last six months
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Isolated failure of the right heart chamber
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Treatment based on night time APD therapy combined with a day time long dwell.
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Obtained written consent to participate in the study.
Exclusion Criteria:
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End stage renal disease requiring dialysis.
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Malignant disease.
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On-going infection.
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Diabetes mellitus.
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HIV and/or hepatitis positive.
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Pregnancy.
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Breastfeeding women.
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Participation in other clinical trials within one month before inclusion.
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Abdominal hernia.
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Cardiac diseases other than left ventricular heart failure, biventricular heart failure or isolated right heart chamber failure, with volume overload.
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Any immune deficiency.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division of Nephrology, Heidelberg University Hospital | Heidelberg | Germany | 69120 |
Sponsors and Collaborators
- Triomed AB
Investigators
- Principal Investigator: Christian Morath, PD Dr. Med, Division of Nephrology, Heidelberg University Hospital, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP Version 1D/2015-12-02
- CIV-14-07-012440
- Tmed-002