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.

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Dialysis
• Intervention / Treatment: Device: lCarry Life System Peritoneal Dialysis (CLS PD)

Detailed Description

Each patient will be studied during a daytime treatment session of 8 hours. After the inclusion criteria have been met the patient will undergo a Personal Dialysis Capacity test (PDC) to establish the characteristics of the peritoneal membrane, which is required for the individual glucose-salt setting in the device. An ECG and coagulation status will also be performed at this visit.

The clinical study requires the insertion of a temporary catheter (Pigtail) in addition to the patients existing standard PD catheter, and it will be inserted on the morning of the study session. Once the temporary catheter is in situ the peritoneal cavity is filled with a standard glucose based PD solution. Heparin will be added to the PD solution to prevent clogging of the CLS PD. The device is then connected to the catheters and the temporary catheter is used for inflow and positioned in the upper right abdominal quadrant whereas the standard PD catheter in the lower quadrant is used for outflow.

During the study session, a glucose-salt solution will be delivered at a set rate according to individual prescriptions based on the PDC-test and a dosage table based on an algorithm. The osmolarity of the intraperitoneal fluid should be approximately 325 mOsmol/L to obtain an average ultrafiltration of roughly 100 ml/h. It is possible to adjust the delivery rate of the glucose-salt solution during the study session to maintain the desired osmolarity.

The Purcart used for removal of uremic toxins requires replacement after 4 hours of treatment. The use of two Purcarts during the eight-hour study session will provide adequate information with regard to the efficacy of toxin removal.

After the study session, the temporary catheter will be removed and the patient will be hospitalized overnight for observation. The patient will resume their previous PD therapy 36 hours after the study session. The patient's experience of the treatment will be recorded and a follow-up will be performed within 1 week after the study session.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västra Götalands Regionen
    • Gothenburg, Västra Götalands Regionen, Sweden, 413 45
      • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Participation in other clinical trials, which can interfere with this study, within one month before inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single group with CLS PD device; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Open questions associated with the CLS PD	The patient will answer open questions objectively describing the portability of the device, sensation associated with the transfer of intraperitoneal fluid in and out of the abdomen and other treatment related viewpoints.	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).	Electrolytes and glucose will be measured both in the blood and the intraperitoneal fluid during the study sessions. The incidence of treatment emergent adverse events or adverse device events occurring during the study	Followed during a three week period from visit 2 to visit 4 (1 day follow-up)

Collaborators and Investigators

• Sponsor: Triomed AB
• Investigators: Principal Investigator: Ola Samuelsson, MD, Renal Unit, Sahlgrenska University Hospital, Gothenburg. Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): March 13, 2018
• Study Completion (ACTUAL): March 31, 2018

Study Registration Dates

• First Submitted: May 27, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (ACTUAL): June 16, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: May 1, 2017

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-005 (Gothenburg)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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