Detecting Markers of Kidney Function With Intravenous Microdialysis

NCT03159806 | Withdrawn FDA Device

• 1 other identifier: MD001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. All medical devices to be used are already CE-marked and approved for these purposes.

Conditions

Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Recovery of biochemicals of interest

  Calculation of optimal microdialysis settings for recovery of specific biochemicals by intravenous microdialysis

  6 months

Study Arms (1)

Outpatients

Attendees at the nephrology outpatient clinic at Hammersmith Hospital will be invited to take part in microdialysis sampling

Device: Microdialysis sampling

Interventions

Microdialysis sampling DEVICE

Insertion of CE-marked intravenous microdialysis catheter, use of CE-marked microdialysis pump to collect intravenous microdialysis samples

Outpatients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal cross-section of adults attending outpatient nephrology clinic

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Accunea Ltd.: lead
• Hammersmith Hospitals NHS Trust: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• Innovate UK: collaborator

Study Sites (1)

Hammersmith Hospital

London, W12 0NN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 8270725 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples retained as per hospital lab protocol, microdialysis samples retained until analysis then discarded

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Frederick Tam, MBBChir PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: July 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)