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

Not Applicable

Terminated

• Conditions: Cardio-Renal Syndrome; Heart Failure
• Interventions: Device: CLS UF

• Registration Number: NCT02772146
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-09
• Study Start: 2016-05-11
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-13
• Primary Completion: 2017-01-23
• Study Completion: 2017-01-23
• Status Verified: 2017-02
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device: CLS UF	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.

Primary Outcome Measures

Name	Time	Method
Ultrafiltrated volume	10 hours	Ultrafiltrated volume during a 10 hours study session.

Secondary Outcome Measures

Name	Time	Method
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
Measured glucose levels in the re-circulated PD fluid	10 hours
Patient acceptance of the wearable device	10 hours	Subjective opinion of each patient
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.

Trial Locations

Locations (1)

Division of Nephrology, Heidelberg University Hospital; 🇩🇪 Heidelberg, Germany