Clinical trial NCT03190018: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Dialysis
Lead sponsor: Triomed AB
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention study, pilot/feasibility for proof of concept of peritoneal dialysis with the Carry Life System for Peritoneal Dialysis (CLS PD)
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change in uremic toxins during the study session
timeFrame: During the eight-hour study session
measure: Maintain stable intraperitoneal osmolarity
timeFrame: During the eight-hour study session
measure: Measure ultrafiltered volume
timeFrame: During the eight-hour study session
Secondary outcomes:
measure: Open questions associated with the CLS PD
timeFrame: During eight-hour study session
measure: Any Adverse Event (AE) or Serious Adverse Event (SAE) and any Adverse Device Effect (ADE) or Serious Adverse Device Effect (SADE).
timeFrame: Followed during a three week period from visit 2 to visit 4 (1 day follow-up)
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götalands Regionen
Study officials:
affiliation: Renal Unit, Sahlgrenska University Hospital, Gothenburg. Sweden
name: Ola Samuelsson, MD
role: PRINCIPAL_INVESTIGATOR
References: