FibroScan assessment and outcomes in a dialysis population
Research type
Research Study
Full title
Non-invasive assessment of liver stiffness, hepatic fibrosis risk markers and outcomes in a dialysis population: a single-site prospective study
IRAS ID
292678
Contact name
Oscar Swift
Contact email
Sponsor organisation
East and North Hertfordshire NHS Trust
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The purpose of this study is to gain a better understanding of liver impairment and its relationship with inflammation in dialysis patients.
The liver plays an important role in decontaminating the blood from toxins and other waste products, some of which originate from the gut. Certain factors for liver impairment include diabetes, obesity and high blood pressure, which also occur commonly in dialysis patients. We aim to establish if patients on dialysis have evidence of impaired liver function and whether this may be associated with high levels of inflammation.
This study involves analysis of some blood tests (which can be taken while on dialysis), a painless ultrasound scan of the liver called a FibroScan and an assessment of the amount of fluid in the body. On the day of the study participants will be asked to fast for 3 hours prior to undergoing the FibroScan test which will be performed both before and after dialysis. Examination with FibroScan, also called transient elastography, is a technique used to assess liver stiffness without invasive investigation. The scan takes 5-10 minutes to perform, with immediate results. Both before and after dialysis, participants will also undergo a medical examination by the study investigator and also have an assessment of fluid status by clinical examination and a body composition monitoring. It is anticipated that completing all of the tests (both pre- and post- dialysis) will take no more than 40 minutes.
Relevant sections of patient medical records will be accessed and recorded by the research team as part of the research study. If sections of the medical notes are unclear then the patient's GP will be contacted for clarification.
Following these assessments, no further investigations are required but patients will be followed up over a period of 2 years to evaluate mortality and cardiovascular outcomes.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
21/NW/0154
Date of REC Opinion
23 Jun 2021
REC opinion
Further Information Favourable Opinion