Study to Develop a Breath Analyser to Detect Chronic Kidney Disease

November 3, 2020 updated by: University College, London

Pilot Study to Develop a Breath Analyser to Detect Chronic Kidney Disease

Measure trimethylamine oxide in the breath.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Organic compounds such as trimethylamine oxide (TMAO) accumulate in the blood of patients with kidney disease, and volatile compounds such as TMAO can be detected in the breath.

The investigators wish to develop a breath analyser to measure volatile compounds, such as TMAO in the breath in patients with kidney disease.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Contact

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

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with kidney disease under the care of Royal Free Hospital

Description

Inclusion Criteria:

  • patients with kidney disease under the care of Royal Free Hospital

Exclusion Criteria:

  • patients unable to provide informed consent
  • patients unable to exhale into breath analyser

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients on dialysis
patients with kidney disease treated by dialysis
Diagnostic test: breath
measurement of volatile compounds, such as TMAO in exhaled breath and blood
Other Names:
  • blood sample
patients with chronic kidney disease
patients with chronic kidney disease not treated by dialysis
Diagnostic test: breath
measurement of volatile compounds, such as TMAO in exhaled breath and blood
Other Names:
  • blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of breath TMAO
Time Frame: 3 years
measurement of breath TMAO by breath analyser
3 years

Collaborators and Investigators

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

Sponsor

University College, London

Investigators

  • Principal Investigator: andrew davenport, md, UCL, London

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)

February 10, 2021

Primary Completion (ANTICIPATED)

November 30, 2023

Study Completion (ANTICIPATED)

November 30, 2023

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (ACTUAL)

October 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS 228416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be filed in UCL library as PhD submission

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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