A Feasibility Study of Peritoneal Ultrafiltration With a Wearable Device, CLS UF, That Adds a Glucose-salt Solution to the Intraperitoneal Fluid in the Device, in Order to Maintain a Stable Intraperitoneal Osmolarity and Thereby Enhance Ultrafiltration.

NCT03128073 | Completed

• 1 other identifier: Tmed-004 (Malmö)
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a proof-of-concept, a feasibility study of peritoneal ultrafiltration with a wearable device, Carry Life System Ultrafiltration (CLS UF) and will be performed on 4-6 stable peritoneal dialysis (PD) patients without clinical signs of dehydration. The study session starts with an initial fill of the abdomen, with a standard, glucose based PD solution. The CLS UF device is then connected to the patients existing, PD catheter. A Glucose-salt solution is added to 180 ml of the intraperitoneal fluid which is intermittently transferred from the peritoneal cavity through a closed system using the CLS UF cycler and then returned to the patient. The addition of the Glucose-salt solution maintains a stable intraperitoneal osmolarity and compensates for the glucose uptake and dilution which occurs in standard PD treatments.

Conditions

Ultrafiltration Failure

Keywords

Heart failure, Cardio-Renal Syndrome

Outcome Measures

Primary Outcomes (2)

• Osmolarity in the intraperitoneal fluid and Ultrafiltered volume during a study session.

  Ultrafiltration during the eight hour study session.

  Eight hour study session

• Ultrafiltered volume during a study session.

  To calculate the total ultrafiltration volume both the total fluid intake and the total output will be calculated during the study session. The fluid intake is recorded and subtracted from the total output which consists of: hourly drains, dialysate sample volumes, the total drain of the peritoneal cavity and the urinary output.

  Eight hour study session

Secondary Outcomes (3)

• Electrolyte gap, i.e. the difference between the electrolyte removal (Na+, K+, Ca++, Mg++) calculated theoretically for an isotonic ultrafiltration fluid and the amount actually removed.

  During eight hour study session

• The patient will verbally evaluate the treatment with the CLS UF and give there subjective opinion of the wearable device.

  During eight hour study sessions and in the follow-up visit

• The incidence of treatment emergent adverse events or adverse device events occurring from the start of the first study session (Visit 3) until the last follow up visit will be evaluated and reported.

  From the third study visit to the completion of the follow-up visit

Study Arms (1)

Single group

EXPERIMENTAL

The intervention is with the Carry Life system ultrafiltration (CLS UF) device, which administers a Glucose-salt solution intermittently to a volume of the intraperitoneal fluid in the device.

Device: Carry life system, ultrafiltration (CLS UF)

Interventions

Carry life system, ultrafiltration (CLS UF) DEVICE

The addition of Glucose-salt intermittently to a volume of the intraperitoneal fluid in the device which is then returned to the subject.

Single group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, of more than 18 years of age.
• Prevalent PD patients without clinical signs of dehydration.
• Obtained written consent to participate in the study.

You may not qualify if:

• Active malignant disease.
• On-going infection.
• HIV and/or hepatitis positive.
• Pregnant, breastfeeding or women of childbearing potential without adequate contraceptive precautions.
• Diabetes type 1.
• Abdominal hernias.
• Conditions except the previous that the Investigator assesses as unsuitable for participation.

Sponsors & Collaborators

• Triomed AB: lead

Study Sites (1)

Kidney Unit

Malmo, Skåne County, 205 02, Sweden

Location

MeSH Terms

Conditions

Heart Failure; Cardio-Renal Syndrome

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Study Officials

• Ann-Cathrine Johansson, MD, PhD

  Skånes University Hospital Malmö, Renal Unit, Inga-Marie Nilsson Gatan, 205 02 Malmö

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intervention study, pilot/ feasibility for proof of concept of peritoneal ultrafiltration with the Carry Life system ultrafiltration (CLS UF)

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 25, 2017
• Study Start: April 20, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: March 16, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)