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.

Peritoneal Dialysis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190018
• Other study ID #: Tmed-005 (Gothenburg)
• Status: Completed
• Phase: N/A
• First received: May 27, 2017
• Last updated: April 16, 2018
• Start date: June 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2017
• Source: Triomed AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 31, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Peritoneal Dialysis

Intervention

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.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	Västra Götalands Regionen

Sponsors (1)

Lead Sponsor	Collaborator
Triomed AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maintain stable intraperitoneal osmolarity	Measurement of Glucose and Sodium in the intraperitoneal fluid during the study session	During the eight-hour study session
Primary	Measure ultrafiltered volume	The calculated difference between total output minus total fluid intake	During the eight-hour study session
Secondary	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
Secondary	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)