Kidney DiseasesNCT03159806
Detecting Markers of Kidney Function With Intravenous Microdialysis
An observational study of Kidney Diseases, run by Accunea Ltd. at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Microdialysis sampling
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 1 Dec 2019
- Phase
- Observational
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal cross-section of adults attending outpatient nephrology clinic
Who may be able to join
- Attending nephrology outpatient clinic
- Aged 18-85
- Able to spare 3.5 hours to participate in study
Who cannot join
- Lacks capacity to consent
- Unable to consent in English
- No visible peripheral veins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Diseases
- Being tested
- Microdialysis sampling
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdialysis samplingDevice
Insertion of CE-marked intravenous microdialysis catheter, use of CE-marked microdialysis pump to collect intravenous microdialysis samples
| Study group | Role | What they receive |
|---|---|---|
| Outpatients | Attendees at the nephrology outpatient clinic at Hammersmith Hospital will be invited to take part in microdialysis sampling Receives: Device: Microdialysis sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of biochemicals of interest
Calculation of optimal microdialysis settings for recovery of specific biochemicals by intravenous microdialysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Jul 2019 (estimated)
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accunea Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Hospitals NHS Trust, Imperial College Healthcare NHS Trust, Innovate UK
- Responsible party
- Sponsor
- Investigators
- Frederick Tam, MBBChir PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159806
- Sponsor's protocol ID
- MD001
- Status last verified
- Oct 2020
- First submitted
- 17 May 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Stjernstrom H, Karlsson T, Ungerstedt U, Hillered L. Chemical monitoring of intensive care patients using intravenous microdialysis. Intensive Care Med. 1993;19(7):423-8. doi: 10.1007/BF01724886.
PubMed 8270725
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising the Recovery of Kidney Function Markers Using a CE-marked Intravenous Microdialysis Probe
- ClinicalTrials.gov ID
- NCT03159806
- Acronym / sponsor ID
- MD001
- Conditions
- Kidney Diseases
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Accunea Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Hospitals NHS Trust, Imperial College Healthcare NHS Trust, Innovate UK
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 19 May 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients | – | Device: Microdialysis samplingAttendees at the nephrology outpatient clinic at Hammersmith Hospital will be invited to take part in microdialysis sampling |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal cross-section of adults attending outpatient nephrology clinic
Key inclusion criteria (3 listed)
- Attending nephrology outpatient clinic
- Aged 18-85
- Able to spare 3.5 hours to participate in study
Key exclusion criteria (3 listed)
- Lacks capacity to consent
- Unable to consent in English
- No visible peripheral veins
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 |
|---|---|---|
| Microdialysis samplingInsertion of CE-marked intravenous microdialysis catheter, use of CE-marked microdialysis pump to collect intravenous microdialysis samples | Device | Outpatients |
Primary outcome
Recovery of biochemicals of interest
Time frame: 6 months
Calculation of optimal microdialysis settings for recovery of specific biochemicals by intravenous microdialysis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 8270725Stjernstrom H, Karlsson T, Ungerstedt U, Hillered L. Chemical monitoring of intensive care patients using intravenous microdialysis. Intensive Care Med. 1993;19(7):423-8. doi: 10.1007/BF01724886.
- Individual participant dataSharing planned: No
Related trials for Kidney Diseases
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Evaluation of Efficacy, Safety, and Tolerability of Povetacicept in Participants With Primary Membranous Nephropathy (pMN)
Primary Membranous Nephropathy
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
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.
Frederick Tam, MBBChir PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases, run by Accunea Ltd. at 1 site in United Kingdom.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Oct 2020. 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 United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Recovery of biochemicals of interest (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03159806, which also lists 1 linked publication.
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 14 Oct 2020.