A Feasibility Study of Peritoneal Ultrafiltration With a Wearable Device, CLS UF, That Adds a Glucose-salt Solution to the Intraperitoneal Fluid in the Device, in Order to Maintain a Stable Intraperitoneal Osmolarity and Thereby Enhance Ultrafiltration.

Overview

The study is a proof-of-concept, a feasibility study of peritoneal ultrafiltration with a wearable device, Carry Life System Ultrafiltration (CLS UF) and will be performed on 4-6 stable peritoneal dialysis (PD) patients without clinical signs of dehydration. The study session starts with an initial fill of the abdomen, with a standard, glucose based PD solution. The CLS UF device is then connected to the patients existing, PD catheter. A Glucose-salt solution is added to 180 ml of the intraperitoneal fluid which is intermittently transferred from the peritoneal cavity through a closed system using the CLS UF cycler and then returned to the patient. The addition of the Glucose-salt solution maintains a stable intraperitoneal osmolarity and compensates for the glucose uptake and dilution which occurs in standard PD treatments.

At visit 1: the fulfilment of the inclusion criteria. a medical assessment including vital signs, and a written informed consent are obtained. A peritoneal equilibrium test (PET) is performed at visit 2, which is a semi-quantitative assessment of peritoneal membrane transport function in patients on peritoneal dialysis. The PET test will determine if the subject has a low, medium or high transport capacity which in turn will dictate the Glucose-salt setting required in the CLS UF to achieve the desired ultrafiltration volume. The dosage of the Glucose-salt solution is based on an algorithm and according to the algorithm, the target osmolarity should be 340 mOsmol/L to obtain an ultrafiltration flow rate of approximately 150 ml/h. The study session with the CLS UF will be performed both at visit 3 and 4. If the prescription of the glucose-salt solution has been changed between treatment sessions 1 and 2 there is an option of a 5th visit. The patient will perform the ordinary prescribed PD therapy until the evening before the study session day, according to the prescription of the investigator. The abdomen will be without PD solution during the night. On the morning of the study day an initial assessment of the patient will be performed before starting the study session and thereafter the abdomen will be filled with a fresh of PD solution, immediately followed by a complete drain. The study session starts with a fill of the abdomen with 2000 ml of Physioneal 2.27%. The sodium concentration of the glucose-salt solution and the glucose dosage required to achieve the target osmolarity of 340 mOsm/L in the intraperitoneal fluid is set according to the Glucose dosage table (CIP, Table 3). The CLS UF device will then be connected to the catheter via the patient line and the device started. The study session is performed for 8 hours and Intermittent drains of 180 ml intraperitoneal fluid will be performed hourly to maintain a stable intraperitoneal volume of around 2 liters. A new cycle starts directly after each drain. The patient can at any time start an extra drain if he/she experience discomfort of increased volume in the abdomen. At the end of the session a complete drain of the peritoneal cavity will be performed and the volume measured. During the study session blood and dialysate samples will be taken according to the case report form (CRF). During the study session, the subjects will eat and drink as usual. All intakes and outputs of fluids will be measured. After the completed study sessions (visit 3 \& 4), the Investigator will perform a clinical assessment of the patient and if satisfactory the patient will return home. At visit 6, a follow up visit is performed in which the subject's vital signs are performed. Adverse events are assessed during study session between visit 3 and follow-up (visit 6). An evaluation of the treatment sessions by the subjects is also performed from visit 3 to visit 6.