Peritoneal DialysisNCT03190018
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.
A study testing lCarry Life System Peritoneal Dialysis (CLS PD) in people with Peritoneal Dialysis, run by Triomed AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis
- What is being tested?
- lCarry Life System Peritoneal Dialysis (CLS PD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital
Gothenburg, Västra Götalands Regionen, 413 45
About this study
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.
Read the 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.
- Conditions
- Peritoneal Dialysis
- Being tested
- lCarry Life System Peritoneal Dialysis (CLS PD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lCarry Life System Peritoneal Dialysis (CLS PD)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Single group with CLS PD device | Experimental | 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. Receives: Device: lCarry Life System Peritoneal Dialysis (CLS PD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in uremic toxins during the study session
Measure the uremic toxins before and after the study session to calculate their removal
Measured: During the eight-hour study session
Maintain stable intraperitoneal osmolarity
Measurement of Glucose and Sodium in the intraperitoneal fluid during the study session
Measured: During the eight-hour study session
Measure ultrafiltered volume
The calculated difference between total output minus total fluid intake
Measured: During the eight-hour study session
Secondary outcomes (2)
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.
Measured: 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
Measured: Followed during a three week period from visit 2 to visit 4 (1 day follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start1 Jun 2017
- Primary completion13 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention study, pilot/feasibility for proof of concept of peritoneal dialysis with the Carry Life System for Peritoneal Dialysis (CLS PD)
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Triomed AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ola Samuelsson, MD, Principal investigator, Renal Unit, Sahlgrenska University Hospital, Gothenburg. Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190018
- Sponsor's protocol ID
- Tmed-005 (Gothenburg)
- Status last verified
- May 2017
- First submitted
- 27 May 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03190018
- Acronym / sponsor ID
- Tmed-005 (Gothenburg)
- Conditions
- Peritoneal Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Triomed ABIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention study, pilot/feasibility for proof of concept of peritoneal dialysis with the Carry Life System for Peritoneal Dialysis (CLS PD)
| Arm | Type | Receives |
|---|---|---|
| Single group with CLS PD device | Experimental | Device: lCarry Life System Peritoneal Dialysis (CLS PD)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Active malignant disease.
- On-going infection.
- HIV and/or hepatitis positive.
- Pregnant, breastfeeding or women of childbearing potential without adequate contraceptive precautions.
- Abdominal hernias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Single group with CLS PD device |
Primary outcome
The change in uremic toxins during the study session
Time frame: During the eight-hour study session
Measure the uremic toxins before and after the study session to calculate their removal
Maintain stable intraperitoneal osmolarity
Time frame: During the eight-hour study session
Measurement of Glucose and Sodium in the intraperitoneal fluid during the study session
Measure ultrafiltered volume
Time frame: During the eight-hour study session
The calculated difference between total output minus total fluid intake
2 secondary outcomes
Open questions associated with the CLS PD
Time frame: 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).
Time frame: Followed during a three week period from visit 2 to visit 4 (1 day follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Peritoneal Dialysis
Not yet recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
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Iodine Starch Test Use in Pleuroperitoneal Leak
Peritoneal Dialysis, Peritoneal Dialysis (PD)
RecruitingPhase 2
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication
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Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
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Continuous Glucose Monitoring in Patients With Diabetes on Peritoneal Dialysis
Kidney Disease, Chronic, Peritoneal Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ola Samuelsson, MD principal investigator
Renal Unit, Sahlgrenska University Hospital, Gothenburg. Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lCarry Life System Peritoneal Dialysis (CLS PD) in people with Peritoneal Dialysis, run by Triomed AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in uremic toxins during the study session (time frame: During the eight-hour study session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018; AzTrials last refreshed its copy on 4 Nov 2026.