A Feasibility Study of Peritoneal Dialysis With CLS PD, Which Removes Toxins and Maintains a Stable Ultrafiltration by Continuously Regenerating a Recirculating Intraperitoneal Fluid, in Patients With End Stage Renal Disease, ESRD, With PD Therapy.

NCT03190018 | Completed

• 1 other identifier: Tmed-005 (Gothenburg)
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a proof-of-concept of peritoneal dialysis with the Carry Life System for Peritoneal Dialysis (CLS PD). The extra-corporeally absorption of uremic toxins and certain ions from the recirculated peritoneal fluid by the Purcart are evaluated together with the achievement of a stable intraperitoneal osmolarity.

Conditions

Peritoneal Dialysis

Outcome Measures

Primary Outcomes (3)

• The change in uremic toxins during the study session

  Measure the uremic toxins before and after the study session to calculate their removal

  During the eight-hour study session

• Maintain stable intraperitoneal osmolarity

  Measurement of Glucose and Sodium in the intraperitoneal fluid during the study session

  During the eight-hour study session

• Measure ultrafiltered volume

  The calculated difference between total output minus total fluid intake

  During the eight-hour study session

Secondary Outcomes (2)

• Open questions associated with the CLS PD

  During eight-hour study session

• Any Adverse Event (AE) or Serious Adverse Event (SAE) and any Adverse Device Effect (ADE) or Serious Adverse Device Effect (SADE).

  Followed during a three week period from visit 2 to visit 4 (1 day follow-up)

Study Arms (1)

Single group with CLS PD device

EXPERIMENTAL

Aim of the intervention is to evaluate the adsorbs of uremic toxins and certain ions with Purcart and the evaluation of the glucose-salt solution ability to achieve stable osmolality. The intervention is during an eight hour study session.

Device: lCarry Life System Peritoneal Dialysis (CLS PD)

Interventions

lCarry Life System Peritoneal Dialysis (CLS PD) DEVICE

The assigned intervention is with the CLS PD device in patients currently receiving peritoneal dialysis for the duration of one study session. A temporary Pigtail catheter is inserted on the same morning as the study session and removed after the session on the same day.

Single group with CLS PD device

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, \>18 years of age.
• Prevalent PD patients with ESRD on stable PD without clinical signs of dehydration
• Obtained written consent to participate in the study.
• Negative pregnancy test in females of childbearing age.

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.
• Abdominal hernias.
• Previous major abdominal surgery.
• Any coagulation disorders.
• Anticoagulant therapy within 7 days prior to the study session.
• Allergy to Ecvacillin or Heparin
• Decompensated heart failure
• Conditions except the previous that the Investigator assesses as unsuitable for participation.

Sponsors & Collaborators

• Triomed AB: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götalands Regionen, 413 45, Sweden

Location

Study Officials

• Ola Samuelsson, MD

  Renal Unit, Sahlgrenska University Hospital, Gothenburg. Sweden

  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 dialysis with the Carry Life System for Peritoneal Dialysis (CLS PD)

Study Record Dates

• First Submitted: May 27, 2017
• First Posted: June 16, 2017
• Study Start: June 1, 2017
• Primary Completion: March 13, 2018
• Study Completion: March 31, 2018
• Last Updated: April 17, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)