The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid. The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment. The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions. Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber. Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane).
Peritoneal dialysis (PD) is a life-sustaining renal replacement therapy for patients with end-stage kidney disease (ESKD). With PD, waste solutes and excess water are drawn from the blood across the peritoneal membrane lining the abdominal cavity via diffusion and osmosis, respectively, into dialysis fluid (peritoneal dialysate) that is introduced into the abdominal cavity through a permanent tube (peritoneal catheter). The peritoneal dialysate is replaced 4-6 times/day either manually by the patient or automatically by a machine at night while the patient is asleep. PD is a gentle dialysis technique that provides continuous gradual dialysis while the patient is free to move during the day. However, PD has several disadvantages. Removal of waste solutes is inadequate and technique failure rate is high, contributing to poor quality of life and high (co)morbidity and mortality (10-15% per year). The low solute clearance (\~1-7% of that of healthy kidneys (depending on the solute) and lower than that with haemodialysis (HD)) is due to rapid decrease of diffusive transport of solutes during a dwell due to the disappearance of the plasma-to-dialysate concentration gradient across the peritoneal membrane. The limited technique survival (median 3.7 years) is primarily due to the high incidence of recurrent infection of the peritoneal membrane (peritonitis) and exposure of the peritoneal membrane to very high, harmful glucose concentrations needed for osmotic fluid removal. Both peritonitis and high glucose concentrations cause pathological changes of the peritoneal membrane and eventually ultrafiltration failure necessitating a switch to the more invasive and expensive HD treatment. To reduce the existing shortcomings of conventional PD, a novel continuous flow peritoneal dialysis system with dialysate regeneration (WEAKID) for PD was developed. WEAKID treatment is based on continuous recirculation of peritoneal dialysate via the single lumen peritoneal catheter with regeneration of spent dialysate by means of sorbent technology. The WEAKID nighttime system (weight: \~12 kg) is intended to be used for 8h per day (during the night) on a daily basis. Instead of performing 4-6 exchanges with fresh peritoneal dialysate per day, WEAKID uses one peritoneal dialysate filling which is continuously recirculated and regenerated. The continuous regeneration prevents saturation of the dialysate with toxins and thereby maintains a high plasma to dialysate concentration gradient which enhances diffusive transport of uremic toxins. In addition, the continuous recirculating flow of fluid along the peritoneal membrane is expected to increase the mass transfer area coefficient as observed in previous studies with continuous flow peritoneal dialysis, probably due to reduction of diffusion resistance, renewal of stagnant fluid layers at the tissue surface and an increase of the effective membrane area. Both the high plasma to dialysate concentration gradient and the increase in mass transfer contribute to an enhancement of the clearance. Another advantage of the WEAKID system is that the glucose peak load to peritoneum is lower than with traditional automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD) thanks to the buffering of the sorbents (sorbents adsorb glucose at the start, lowering the initial glucose peak, and release the glucose again at later stage) and the continuous recirculation. The primary objective of this study is to assess the (short-term) safety of the WEAKID nighttime system in a limited number (n=12) of patients and sessions (6 sessions per patient). Secondary objectives of this study are: 1. To evaluate the incidence of adverse events (AEs) and device deficiencies (DDs) other than serious adverse device effects (SADEs) and DDs that could have led to a serious adverse event (SAE) 2. To describe the characteristics of WEAKID treatment (i.e. number and duration of sessions, dialysate flow rates) 3. To evaluate the clinical condition and vital signs of the participants during WEAKID treatment 4. To evaluate the effectiveness of ultrafiltration (UF) in relation to glucose concentration during WEAKID treatment 5. To evaluate the efficacy of solute removal and base release of WEAKID treatment 6. To evaluate the evolution of plasma analytes during WEAKID treatment 7. To evaluate the evolution of dialysate effluent analytes of the WEAKID system 8. To evaluate the (technical) device performance of the WEAKID system by the number of device deficiencies, adverse device effects and changes in intraperitoneal pressure 9. To evaluate patient tolerance during WEAKID treatment 10. To evaluate the evolution of uremic symptoms during WEAKID treatment 11. To evaluate the effectiveness of using sorbents for dialysate regeneration and the effectiveness of continuous recirculating flow in relation to the efficacy of solute removal. The WEAKID system will be tested in a clinical setting on 6 days over a period of 2 weeks. During the first week, the subjects will be treated with the nighttime system without sorbents for 4h (first day) or 8h (second and third day) during daytime. The second week, treatment will consist of the nighttime system with sorbents (also 4h (first day) or 8h (second and third day) during daytime). This way, exposure to new components of the system is incremental and the effectiveness of the sorbents can be analyzed separately from the effect of continuous recirculating flow dialysis. A peritoneal equilibration test (PET) will be performed at baseline and follow-up. In addition, patients will collect 24h spent peritoneal dialysate and 24h urine followed by venous puncture for blood sampling 3 times prior to WEAKID treatment during standard PD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Six treatments over the course of two weeks with the WEAKID system: * Week 1 (without the sorbents) * Day 1: four-hour treatment * Day 2: eight-hour treatment * Day 3: eight-hour treatment * Week 2 (with the sorbents) * Day 1: four-hour treatment * Day 2: eight-hour treatment * Day 3: eight-hour treatment
Università degli studi di Modena e Reggio Emilia (UNIMORE)
Modena, Modena, Italy
NOT_YET_RECRUITINGUniversity Medical Center Utrecht (UMCU)
Utrecht, Utrecht, Netherlands
RECRUITINGHospital Universario La Paz (SERMAS)
Madrid, Madrid, Spain
NOT_YET_RECRUITINGSerious adverse device effects (SADEs) and device deficiencies (DDs)
Serious adverse device effects (SADEs) and device deficiencies (DDs) that could have led to a serious adverse event
Time frame: This will be assessed through study completion (four weeks in total per participant)
Critical changes in blood pressure
Critical changes requiring intervention in blood pressure (measured in mmHg; both systolic and diastolic pressures will be assessed).
Time frame: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Critical changes in heart rate
Critical changes requiring intervention in heart rate (measured in beats per minute).
Time frame: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Critical changes in body temperature
Critical changes requiring intervention in body temperature (measured in °C).
Time frame: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Critical changes in oxygen saturation
Critical changes requiring intervention in oxygen saturation (measured in %).
Time frame: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Critical changes in plasma potassium
Critical changes requiring intervention in plasma potassium (before and after WEAKID treatment in mmol/L).
Time frame: This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Critical changes in plasma calcium
Critical changes requiring intervention in plasma calcium (before and after WEAKID treatment in mmol/L).
Time frame: This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Critical changes in plasma bicarbonate
Critical changes requiring intervention in plasma bicarbonate (before and after WEAKID treatment in mmol/L).
Time frame: This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Critical changes in intra-abdominal dialysate volume
Critical changes requiring intervention in intra-abdominal dialysate volume.
Time frame: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Critical changes in intra-abdominal pressure
Critical changes requiring intervention in intra-abdominal dialysate pressure (in mbar).
Time frame: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Adverse events (AEs) and device deficiencies (DDs)
Assessing incidence of adverse events (AEs) and device deficiencies (DDs) other than SADEs and DDs that could have led to an serious adverse event (SAE).
Time frame: This will be assessed through study completion (four weeks in total per participant)
Number of WEAKID treatments
The number of WEAKID treatments per patient will be determined
Time frame: The number of WEAKID treatments will be assessed for the study treatment period (2 weeks in total per participant)
Duration of WEAKID treatments
Duration of each WEAKID treatment will be assessed (in minutes).
Time frame: This will be assessed for each WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Dialysate flow rates during WEAKID treatment
Dialysate flow rates will be determined during each WEAKID treatment (in mL/min).
Time frame: This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of blood pressure
Blood pressure will be measured multiple times during a WEAKID treatment to examine its evolution during treatment (in mmHg).
Time frame: This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Evolution of heart rate
Heart rate will be measured multiple times during a WEAKID treatment to examine its evolution during treatment (in beats per minute).
Time frame: This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Evolution of body temperature
Body temperature will be measured multiple times during a WEAKID treatment to examine its evolution during treatment (in °C).
Time frame: This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Evolution of oxygen saturation
Oxygen saturation will be measured multiple times during a WEAKID treatment to examine its evolution during treatment (in %).
Time frame: This will be assessed during WEAKID treatment at t=0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Ultrafiltration volume
For each WEAKID session, ultrafiltration volume will be determined (in mL).
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Peak glucose concentration in the device effluent
For each WEAKID session, peak glucose concentration in the effluent of the device will be determined (in mmol/L).
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Ultrafiltration efficiency
For each session, ultrafiltration efficiency (volume of osmotic water removal per gram absorbed glucose) will be determined (in mL/gram absorbed glucose).
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Removal of urea by the WEAKID system
The removal of urea (in mmol) by the WEAKID system will be determined for each WEAKID treatment
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Removal of creatinine by the WEAKID system
The removal of creatinine (in mmol) by the WEAKID system will be determined for each WEAKID treatment
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Removal of phosphate by the WEAKID system
The removal of phosphate (in mmol) by the WEAKID system will be determined for each WEAKID treatment
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Removal of potassium by the WEAKID system
The removal of potassium (in mmol) by the WEAKID system will be determined for each WEAKID treatment
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Removal of beta-2 microglobulin by the WEAKID system
The removal of beta-2 microglobulin (in mmol) by the WEAKID system will be determined for each WEAKID treatment
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Mass transfer area coefficient of urea
The mass transfer area coefficient (MTAC) for urea will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Mass transfer area coefficient of creatinine
The mass transfer area coefficient (MTAC) for creatinine will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Mass transfer area coefficient of phosphate
The mass transfer area coefficient (MTAC) for phosphate will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Mass transfer area coefficient of potassium
The mass transfer area coefficient (MTAC) for potassium will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Mass transfer area coefficient of beta-2 microglobulin
The mass transfer area coefficient (MTAC) for beta-2 microglobulin will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Plasma clearance of urea
The plasma clearance of urea will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Plasma clearance of creatinine
The plasma clearance of creatinine will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Plasma clearance of phosphate
The plasma clearance of phosphate will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Plasma clearance of potassium
The plasma clearance of potassium will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Plasma clearance of beta-2 microglobulin
The plasma clearance of beta-2 microglobulin will be determined for each WEAKID treatment (in mL/min)
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
The plasma reduction ratio of the protein-bound uremic toxin p-cresyl sulfate
The plasma reduction ratio of p-cresyl sulfate will be calculated using the plasma concentrations before and after each WEAKID treatment.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
The plasma reduction ratio of the protein-bound uremic toxin p-cresyl glucuronide
The plasma reduction ratio of p-cresyl glucuronide will be calculated using the plasma concentrations before and after WEAKID treatment.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
The plasma reduction ratio of the protein-bound uremic toxin indole acetic acid
The plasma reduction ratio of indole acetic acid will be calculated using the plasma concentrations before and after WEAKID treatment.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
The plasma reduction ratio of the protein-bound uremic toxin kynurenine
The plasma reduction ratio of kynurenine will be calculated using the plasma concentrations before and after WEAKID treatment.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
The plasma reduction ratio of the protein-bound uremic toxin kynurenic acid
The plasma reduction ratio of kynurenic acid will be calculated using the plasma concentrations before and after WEAKID treatment.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
The plasma reduction ratio of the protein-bound uremic toxin hippuric acid
The plasma reduction ratio of hippuric acid will be calculated using the plasma concentrations before and after WEAKID treatment.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
The release of base
The release of base (in mmol) will be determined by calculating the sum of the release of bicarbonate (in mmol) and that of lactate (in mmol) for each WEAKID treatment
Time frame: This will be assessed for every WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of urea
Urea plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of creatinine
Creatinine plasma levels (in micromol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of uric acid
Uric acid plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of beta-2 microglobulin
Beta-2 microglobulin plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of phosphate
Phosphate plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of potassium
Potassium plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of bicarbonate
Bicarbonate plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of lactate
Lactate plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of sodium
Sodium plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of chloride
Chloride plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of calcium
Calcium plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of magnesium
Magnesium plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of glucose
Glucose plasma levels (in mmol/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of lactate dehydrogenase
Lactate dehydrogenase plasma levels (in U/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of vitamin B12
Vitamin B12 plasma levels (in mg/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of albumin
Albumin plasma levels (in g/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma leucocyte count
Leucocyte count in plasma (in x10\^9/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma thrombocyte count
Thrombocyte count in plasma (in x10\^9/L) will be determined before and after every WEAKID session.
Time frame: These will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant)
Evolution of plasma levels of C-reactive protein (CRP)
CRP plasma levels (in mg/L) will be determined before and after every series of three WEAKID sessions.
Time frame: This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant)
Evolution of plasma levels of bilirubin
Bilirubin plasma levels (in umol/L) will be determined before and after every series of three WEAKID sessions.
Time frame: This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant)
Evolution of plasma levels of aspartate transaminase (ASAT)
ASAT plasma levels (in U/L) will be determined before and after every series of three WEAKID sessions.
Time frame: This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant)
Evolution of plasma levels of alanine aminotransferase (ALAT)
ALAT plasma levels (in U/L) will be determined before and after every series of three WEAKID sessions.
Time frame: This will be assessed before and after every series of three WEAKID treatment throughout the study treatment period (two times per week, two weeks in total per participant)
Evolution of sodium levels in dialysate effluent
Sodium levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.
Time frame: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Evolution of chloride levels in dialysate effluent
Chloride levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.
Time frame: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Evolution of calcium levels in dialysate effluent
Calcium levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.
Time frame: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Evolution of magnesium levels in dialysate effluent
Magnesium levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.
Time frame: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Evolution of bicarbonate levels in dialysate effluent
Bicarbonate levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.
Time frame: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Evolution of lactate levels in dialysate effluent
Lactate levels (in mmol/L) will be determined in dialysate effluent at various timepoints during every WEAKID treatment.
Time frame: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Evolution of pH of dialysate effluent
pH of dialysate effluent will be determined at various timepoints during every WEAKID treatment.
Time frame: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Total number of device deficiencies and adverse device effects
All device deficiencies (DDs) and adverse device effects (ADEs) will be reported and quantified.
Time frame: This will be assessed through study completion (four weeks in total per participant)
Evolution of delta intraperitoneal pressure during WEAKID treatment
Delta intraperitoneal pressure will be calculated using the following formula: intraperitoneal pressure during WEAKID treatment (in mbar) - intraperitoneal pressure at t=0 (in mbar). Intraperitoneal pressure is determined using the pressure sensors of the WEAKID device.
Time frame: This will be assessed during WEAKID treatment at t=15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours (for 8-hour treatment), and 8 hours (for 8-hour treatment) throughout the study treatment period (2 weeks in total per participant)
Patient tolerance (abdominal discomfort)
Abdominal discomfort (scored using a numeric rating scale between 0-10) will be determined multiple times throughout the study period.
Time frame: This will be assessed at baseline, during every WEAKID treatment (at t = 0 minutes, 15 minutes, 1 hour, 2 hours, 4 hours, and 8 hours (for 8-hour treatment), and at the end of the study period (4 weeks in total per participant).
Evolution of uremic symptoms
Uremic symptoms will be scored using the Dialysis Symptom Index questionnaire; this is a questionnaire consisting of thirty yes/no questions regarding whether participants have experienced a certain symptom during the last week. If the answer is yes, the participant will score how much they have felt burdened by this specific symptom during the last week on a Likert scale from 0-4; the higher the score, the more burdened the participant felt.
Time frame: This will be assessed at baseline and on the day of the last WEAKID treatment of each treatment week (three times during three weeks in total per participant).