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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-03-16

No results posted yet for this study

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

Interventions

DEVICE

Carry life system, ultrafiltration (CLS UF)

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

Sponsors & Collaborators

  • Triomed AB

    lead INDUSTRY

Principal Investigators

  • Ann-Cathrine Johansson, MD, PhD · Skånes University Hospital Malmö, Renal Unit, Inga-Marie Nilsson Gatan, 205 02 Malmö

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03128073 on ClinicalTrials.gov