Detecting Markers of Kidney Function With Intravenous Microdialysis

October 12, 2020 updated by: Accunea Ltd.

Optimising the Recovery of Kidney Function Markers Using a CE-marked Intravenous Microdialysis Probe

Patients will be invited to participate from an outpatient nephrology clinic at Hammersmith Hospital. They will have a microdialysis catheter inserted into a peripheral vein and connected to a sampling system. The samples will be sent for analysis in the hospital laboratory. All medical devices to be used are already CE-marked and approved for these purposes.

Study Overview

Status

Status

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Withdrawn

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

Patients attending Professor Tam's outpatient clinic will be invited to participate in the study. After time to read the relevant protocol and consent form, and agreeing to proceed, a patient will be taken to a separate room in the outpatient department by Dr. Robert M. Learney.

In this room, the patient will have a suitable vein identified on the forearm or back of the hand. Dr. Learney will then insert a venous cannula into the vein with aseptic technique, secure it in place, and then draw a 3-5mL preliminary blood sample for creatinine and potassium analysis in the hospital lab. Outpatients attending the nephrology department would have one blood test for these biochemicals (and others) taken as part of routine care anyway. This sampling would replace the routine blood test for this attendance.

Dr. Learney will then insert a single-use type 67 intravenous microdialysis catheter into the venous cannula, attach a sampling vial to the outlet of the catheter, and a pump for delivering a sterile saline solution to the inlet of the catheter. All devices and liquids are CE-marked and licensed for human use. Half of the 20 patients in the study will have a short 1cm microdialysis catheter inserted, and half will have a longer 2cm microdialysis catheter inserted.

The pump will be started at a flow rate of 2 microlitres per minute, and 50 microlitres of sample will be collected over the next 25 minutes. The patient will be free to walk around and/or read a book, but must return at the end of 30 minutes for the sample vial to be exchanged for a new one. At this point the pump flow rate will be adjusted down to 1 microlitre per minute by turning a small dial on the side. The patient will be free again for the next 50 minutes to produce the next 50 microlitres of sample. The sample vial will be exchanged again at this point, and the flow rate adjusted down one final time to 0.5 microlitres per minute for 100 minutes to collect a final 50 microlitres of sample.

After this final experiment, the patient will have the microdialysis catheter removed from the cannula for inspection and disposal. A final 3-5mL blood sample will be withdrawn from the cannula, and if this is not possible then it will be taken from a different visible vein. These first and last blood draws ensure that the baseline levels of the two chemicals of interest have not changed significantly during the three hours of the experiment.

All samples collected in this experiment will be assayed in the hospital laboratory for the biochemicals of interest.

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.
Observational

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

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normal cross-section of adults attending outpatient nephrology clinic

Description

Inclusion Criteria:

  • Attending nephrology outpatient clinic
  • Aged 18-85
  • Able to spare 3.5 hours to participate in study

Exclusion Criteria:

  • Lacks capacity to consent
  • Unable to consent in English
  • No visible peripheral veins

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Outpatients
Attendees at the nephrology outpatient clinic at Hammersmith Hospital will be invited to take part in microdialysis sampling
Device: Microdialysis sampling
Insertion of CE-marked intravenous microdialysis catheter, use of CE-marked microdialysis pump to collect intravenous microdialysis samples

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
Recovery of biochemicals of interest
Time Frame: 6 months
Calculation of optimal microdialysis settings for recovery of specific biochemicals by intravenous microdialysis
6 months

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.
Accunea Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Imperial College Healthcare NHS Trust
Hammersmith Hospitals NHS Trust
Innovate UK

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: Frederick Tam, MBBChir PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

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.
July 1, 2019

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.
December 1, 2019

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.
December 1, 2019

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).
May 17, 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.
May 17, 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.
May 19, 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.
October 14, 2020

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.
October 12, 2020

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.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • MD001

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

Yes

product manufactured in and exported from the U.S.

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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