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.

March 15, 2018 updated by: Triomed AB
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Malmö, Skåne, Sweden, 205 02
        • Kidney Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients, of more than 18 years of age.
  • Prevalent PD patients without clinical signs of dehydration.
  • Obtained written consent to participate in the study.

Exclusion Criteria:

  • Active malignant disease.
  • On-going infection.
  • HIV and/or hepatitis positive.
  • Pregnant, breastfeeding or women of childbearing potential without adequate contraceptive precautions.
  • Diabetes type 1.
  • Abdominal hernias.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single group
The intervention is with the Carry Life system ultrafiltration (CLS UF) device, which administers a Glucose-salt solution intermittently to a volume of the intraperitoneal fluid in the device.
Device: Carry life system, ultrafiltration (CLS UF)
The addition of Glucose-salt intermittently to a volume of the intraperitoneal fluid in the device which is then returned to the subject.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Osmolarity in the intraperitoneal fluid and Ultrafiltered volume during a study session.
Time Frame: Eight hour study session
Ultrafiltration during the eight hour study session.
Eight hour study session
Ultrafiltered volume during a study session.
Time Frame: Eight hour study session
To calculate the total ultrafiltration volume both the total fluid intake and the total output will be calculated during the study session. The fluid intake is recorded and subtracted from the total output which consists of: hourly drains, dialysate sample volumes, the total drain of the peritoneal cavity and the urinary output.
Eight hour study session

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Electrolyte gap, i.e. the difference between the electrolyte removal (Na+, K+, Ca++, Mg++) calculated theoretically for an isotonic ultrafiltration fluid and the amount actually removed.
Time Frame: During eight hour study session
Measurement of electrolytes in serum and intraperitoneal fluid during the study session.
During eight hour study session
The patient will verbally evaluate the treatment with the CLS UF and give there subjective opinion of the wearable device.
Time Frame: During eight hour study sessions and in the follow-up visit
The patient will verbally evaluate the treatment with the CLS UF (e.g. related to the intermittent transfer of intraperitoneal fluid in and out of the device). The patient give their subjective opinion of the wearable device (e.g. related to the weight, ease of movement, comfort etc.)
During eight hour study sessions and in the follow-up visit
The incidence of treatment emergent adverse events or adverse device events occurring from the start of the first study session (Visit 3) until the last follow up visit will be evaluated and reported.
Time Frame: From the third study visit to the completion of the follow-up visit
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 from the start of the first study session (Visit 3) until the last follow up visit will be evaluated and reported.
From the third study visit to the completion of the follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Triomed AB

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ann-Cathrine Johansson, MD, PhD, Skånes University Hospital Malmö, Renal Unit, Inga-Marie Nilsson Gatan, 205 02 Malmö

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tmed-004 (Malmö)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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