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

NCT03724682 | Completed

• 1 other identifier: Tmed-007 (Malmö)
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

• Ultrafiltration volume

  The ultrafiltration volumes achieved during the study sessions

  During a five hour study session

Study Arms (1)

Single arm

EXPERIMENTAL

Single arm in which everyone enrolled in a trial receives treatment with Carry Life UF device,

Device: Carry Life UF device

Interventions

Carry Life UF device DEVICE

Treatment with the Carry Life UF device compared to standard PD therapy

Single arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Triomed AB: lead

Study Sites (3)

Skånes Universitetssjukhus, Malmö

Malmo, Skåne County, 205 02, Sweden

Location

Skånes Universitetssjukhus, Lund

Lund, Sweden

Location

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Related Publications (1)

• Heimburger O, Hegbrant J, Martus G, Wilkie M, De Leon C, Carlsson O, Johansson AC. Effects of Steady Glucose Concentration Peritoneal Dialysis on Ultrafiltration Volume and Sodium Removal: A Pilot Crossover Trial. Clin J Am Soc Nephrol. 2024 Feb 1;19(2):224-232. doi: 10.2215/CJN.0000000000000342. Epub 2023 Oct 30.

  PMID: 37902732 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann-Cathrine Johansson

  Renal Unit, Skånes Universitetssjukhus, Malmö

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Baseline study session with standard PD therapy. Three study sessions with the Carry Life UF device at three different glucose dosages, starting with the lowest dose of 11g/h, increasing to 14g/h and finally 20g/h.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: March 1, 2019
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: August 28, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)