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

Launched by TRIOMED AB · Oct 29, 2018

Keywords

ClinConnect Summary

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 th...

Gender

ALL

Eligibility criteria

• 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