A Performance Analysis of the Peritoneal Ultrafiltration (PUF) Achieved With the Carry Life® UF

The Carry Life UF device performs peritoneal ultrafiltration by adding a concentrated glucose to peritoneal dialysis fluid which has been instilled into the abdomen prior to the connection of the device. Maintaining the glucose concentration in the intraperitoneal fluid results in an increased fluid removal (ultrafiltration).

The clinical investigation will evaluate the ultrafiltration achieved with the Carry Life UF device compared to standard peritoneal dialysis (PD) therapy

Study Overview

• Status: Completed
• Conditions: Chronic Renal Failure
• Intervention / Treatment: Device: Carry Life UF device

Detailed Description

A study of the peritoneal ultrafiltration achieved with Carry Life® UF compared to standard PD therapy, performed in 12 stable PD patients. The study consists of one baseline study session with Icodextrin overnight and one four-hour, 2.27% glucose exchange and three Carry Life® UF treatments with different glucose doses. All treatments are preceded by an Icodextrin dwell overnight.

Visit 1: The patient will be screened for study eligibility and a signed informed consent obtained before any of the study activities commence. Once included in the study the patient will be asked to document their ultrafiltration volumes for the week prior to the baseline study session (PD bags to be weighed before and after).

Visit 2: Baseline study session with standard PD therapy. The evening before visit 2 the patient will use Icodextrin 2000 ml overnight which is drained at the clinic before the start of the second PD exchange.

• A four-hour dwell with 2.27%, 2000 ml PD fluid will be performed at the clinic.
• During the study sessions the fluid intake and output will be measured.
• A 24 h urine collection for urea and creatinine clearance started the day before the baseline study session will be completed at the baseline study session.

Visit 3, 4 and 5: Carry Life® UF study sessions The evening before the visits the patient will use Icodextrin 2000 ml overnight which is drained at the clinic the next day before the start of the Carry Life® UF study session.

• The Carry Life UF study session starts with filling the peritoneal cavity with 1500 ml of a standard glucose-based PD solution of 1.36%.
• The Carry Life® UF is then connected to the PD catheter and the 5-hour treatment starts. The glucose dose for visit 3 is 11 g/h, visit 4, 14 g/h and visit 5, 20 g/h.
• During the treatment, IP fluid will be drained hourly and as required.
• During the study sessions the fluid intake and output will be measured.
• During and after each study session the patient's tolerability of the treatment will be evaluated by monitoring vital signs (blood pressure and heart rate hourly).
• Evaluation of the patient's experience of the Carry Life® UF treatment is documented in the CRF, regarding the sensation of the flow in and out of the abdomen and a short questionnaire between visit 4 and 5, regarding the usability and experience of the device.

Follow-up: Follow-up will be performed after the completion of the Carry Life® UF study sessions. The follow-up can either be performed at the clinic or by telephone which is at the discretion of the investigator and the patient.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden
    • Skånes universitetssjukhus, Lund
  • Stockholm, Sweden
    • Karolinska Universitetssjukhuset
  • Skåne
    • Malmö, Skåne, Sweden, 205 02
      • Skånes Universitetssjukhus, Malmö

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years
• Male or female
• On stable PD including Icodextrin, treated at the clinic for at least 3 months
• No clinical signs of dehydration.
• Obtained written consent to participate in the study

Exclusion Criteria:

• Significant illness or active infection (evaluated by clinical examination) in the past 4 weeks
• Episodes of peritonitis during the past 2 months
• Active malignant disease
• Diabetes type 1
• Abdominal hernias
• HIV and/or hepatitis positive within the last 3 months
• Known pregnancy or breastfeeding and pregnancy test for women of child bearing age.
• Conditions deemed by investigator as inappropriate for participation
• Participation in clinical trials, interfering with the present study, one month prior to inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm; Single arm in which everyone enrolled in a trial receives treatment with Carry Life UF device,	Device: Carry Life UF device; Treatment with the Carry Life UF device compared to standard PD therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrafiltration volume	The ultrafiltration volumes achieved during the study sessions	During a five hour study session

Collaborators and Investigators

• Sponsor: Triomed AB
• Investigators: Principal Investigator: Ann-Cathrine Johansson, Renal Unit, Skånes Universitetssjukhus, Malmö

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 26, 2019
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 30, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: Tmed-007 (Malmö)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The results of the investigation will be submitted for publication, and publications and presentations will be based upon the clinical investigation report.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No