- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03159806
Detecting Markers of Kidney Function With Intravenous Microdialysis
Optimising the Recovery of Kidney Function Markers Using a CE-marked Intravenous Microdialysis Probe
Study Overview
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 A final 3-5mL blood sample will be withdrawn from the cannula, and if this is not possible then it will be taken from a different visible vein.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
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, W12 0NN
- Hammersmith Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Outpatients
Attendees at the nephrology outpatient clinic at Hammersmith Hospital will be invited to take part in 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
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
Sponsor
Investigators
- Principal Investigator: Frederick Tam, MBBChir PhD, Imperial College London
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Kidney Diseases
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
University of North Carolina, Chapel HillLantheus Medical ImagingCompletedChronic Kidney Diseases | Cystic Kidney DiseaseUnited States
-
SanofiTerminatedCongenital Cystic Kidney DiseaseGermany, Spain, United States, Australia, Belgium, Japan, Korea, Republic of, Netherlands
-
University of UtahNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingHemodialysis | Kidney Disease, Chronic | Kidney Failure | Dialysis | Diabetic | End-stage Kidney Disease | Kidney Dysfunction | Non-diabeticUnited States
-
Pang PengGuangdong Provincial Hospital of Traditional Chinese MedicineUnknownEnd-Stage Kidney Disease | Chronic Kidney FailureChina
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
RenJi HospitalUnknownKidney Diseases,CysticChina
-
George Washington UniversityCareDx; VirginiaBio Analytics, LLCTerminatedKidney Diseases | Kidney Failure, Chronic | Kidney Transplant Infection | Kidney Transplant Rejection | Kidney Injury | Kidney Disease, Chronic | Kidney Failure | Kidney Failure, Acute | Kidney Transplant; Complications | Kidney IschemiaUnited States
-
Renibus Therapeutics, Inc.CompletedKidney Failure, AcuteUnited States
-
Emory UniversityNorthwestern University; Columbia University; Satellite Healthcare; Norman S. Coplon...CompletedKidney Failure, Chronic | Kidney Transplantation | End-Stage Kidney DiseaseUnited States
Clinical Trials on Microdialysis sampling
-
Imperial College LondonUniversity College, London; Centre Hospitalier Universitaire Vaudois; Fondazione... and other collaboratorsCompletedTraumatic Brain InjurySwitzerland, United Kingdom, Italy, Slovenia
-
Barts & The London NHS TrustImperial College London; Queen Mary University of LondonRecruitingAortic Aneurysm | Aortic Diseases | Aortic Dissection | Aortic ArchUnited Kingdom
-
Mayo ClinicNational Cancer Institute (NCI)RecruitingGlioblastoma | Anaplastic Astrocytoma | Oligodendroglioma | Diffuse Astrocytoma | Anaplastic Oligodendroglioma | Metastatic Malignant Neoplasm in the Brain | Diffuse GliomaUnited States
-
Centre Hospitalier Universitaire de Saint EtienneUniversity Hospital of Saint-EtienneTerminatedKidney Cancer | Nephrectomy | MicrodialysisFrance
-
Medical University of GrazCompleted
-
Imperial College LondonThe Drummond Foundation (RAMC charity)RecruitingCompartment Syndrome of Leg | Limb IschemiaUnited Kingdom
-
Mayo ClinicEnrolling by invitation
-
Medical University of GrazMenarini GroupCompleted
-
Centre Hospitalier Universitaire, AmiensCompleted
-
Centre Hospitalier Universitaire, AmiensCompleted