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

• ClinicalTrials.gov Identifier: NCT02772146
• Recruitment Status: Terminated
• First Posted: May 13, 2016
• Last Update Posted: March 14, 2017
• Sponsor: Triomed AB
• Information provided by (Responsible Party): Triomed AB

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
Heart Failure; Cardio-Renal Syndrome	Device: CLS UF	Not Applicable

Study Design

• 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

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 Name: Carry LifeTM System Ultra Filtration

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Germany

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

More 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
• 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:

Cardio-Renal Syndrome; Heart Failure; Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases