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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03279419
Other study ID # IRAS ID 189169
Secondary ID
Status Recruiting
Phase N/A
First received September 8, 2017
Last updated September 8, 2017
Start date September 1, 2017
Est. completion date December 1, 2019

Study information

Verified date September 2017
Source University of Edinburgh
Contact Mhairi Donnelly, MBChB
Phone 00447969824902
Email mhairi.donnelly@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a feasibility study, to assess if thermal imaging and/or near infrared imaging will be useful in identifying changes in the peripheral circulation in patients with different stages of liver disease.

The aim of this study is to use new and advanced thermal imaging techniques to identify changes in the peripheral circulation and hand temperature in patients with liver disease. These changes could be used as a non-invasive marker of the severity and progression of liver disease. Thermal imaging will also be used to assess the changes in the peripheral vasculature with the use of terlipressin, a drug used as treatment for specific complications of liver disease.

Patients with acute or chronic liver disease from any aetiology will be recruited, along with patients without liver disease as healthy controls. Patients with disease or on drugs known to affect the peripheral vasculature will be excluded.

All studies will be performed in a ward setting in the Royal Infirmary of Edinburgh. The subjects will be required for up to three sessions, each lasting 30 minutes. The session will involve static thermal images being taken, and video images of the hands warming up after being cooled for 30 seconds in water at a temperature of 7 degrees Celsius. If the patient is receiving terlipressin therapy, static images will be taken before, during and after terlipressin therapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- diagnosis of chronic liver disease (any stage)

- diagnosis of acute liver disease (any aetiology)

Exclusion Criteria:

- on drugs known to affect peripheral circulation

- conditions known to affect peripheral circulation e.g. Raynauds

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Thermal imaging
Use of thermal imaging camera to capture images of peripheral vasculature (hands).

Locations

Country Name City State
United Kingdom Univerity of Edinburgh and NHS Lothian Edinburgh

Sponsors (1)

Lead Sponsor Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in peripheral vasculature as assessed by thermal imaging 2 years
Secondary Changes in peripheral vasculature in response to terlipressin therapy. 2 years
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