Using Bedside Ultrasound to Understand Fluid Management in Patients With Chronic Liver Disease

NCT07810855 | Not Yet Recruiting

• 2 other identifiers: 3750501325/RD
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to see if repeated bedside ultrasound measurements of the lungs and abdomen as well as a blood vessel in the neck can be done in patients with advanced liver disease and ascites (fluid in the abdomen) on hospital wards and day case units. We will also learn about how patients view this test. The main questions it will answer are: How long does it take to do the measurements? How often are we able to get all the measurements we are trying to do? How do patients feel about having this test done? For patients in the study this will involve: Undergoing ultrasound scans of the neck, chest and abdomen on at least one occasion during hospital admission, and up to a maximum of five times in a day. An extra blood test may be taken at the same time as usual blood tests taken during the hospital stay. A brief questionnaire about their experience of having the test.

Conditions

Cirrhosis; Ascites Hepatic; Fluid Balance

Outcome Measures

Primary Outcomes (3)

• Technical success or failure of POCUS readings

  The number of POCUS scans attempted that resulted in a recorded measurement

  From enrollment until the end of the POCUS readings period at 7 days

• Duration of POCUS readings

  Time taken to perform each episode of POCUS during the study period, defined by the start and end times recorded in the case report form

  From enrolment until the end of the POCUS readings period at 7 days

• Patient acceptability

  Structured feedback from participants on the acceptability of the POCUS readings via a questionnaire

  From enrollment until the end of the POCUS readings period at 7 days

Secondary Outcomes (3)

• Changes in POCUS measurements in response to fluid management interventions

  From enrolment until the end of POCUS readings period at 7 days

• Correlation of POCUS readings with clinical assessment

  From enrolment until end of POCUS readings period (7 days)

• Correlation of POCUS readings with clinical outcomes

  From enrolment until 90 days

Interventions

Ultrasound measurement DIAGNOSTIC_TEST

Point-of-care ultrasound measurements of the IJV, IVC, thorax and abdomen performed at least once following recruitments and on up to three separate occasions in total during the first seven days of admission, with up to five measurements in total on each occasion.

Blood draw for the laboratory assessment DIAGNOSTIC_TEST

A blood sample for research analysis may be taken at the same time as standard of care blood tests during the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants under the care of the hepatology team at the Royal Free Hospital will be recruited from the emergency department, wards or ambulatory care.

You may qualify if:

• Participants must be capable of giving informed consent
• Hospitalized patients with liver cirrhosis (of any cause) and clinically significant ascites
• \> 18 years of age

You may not qualify if:

• patients receiving end of life care

Sponsors & Collaborators

• Royal Free Charity: collaborator
• Royal Free Hospital NHS Foundation Trust: lead

MeSH Terms

Conditions

Fibrosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 180 days from the official end of the study with no end date
• Access Criteria: To maximise the scientific value of the data, access to the pseudonymised dataset may be granted to external academic and clinical collaborators. Entry into the collaboration framework is subject to the following criteria: * Collaborators must submit a written request detailing a specific analysis plan or sub-study protocol, approved by the Chief Investigator with oversight from Royal Free R\&D as the sponsor. * No data will be transferred until a formal Data Sharing Agreement (DSA) or Research Collaboration Agreement (RCA) is executed between the Sponsor and the collaborator's host institution. Shared data must be transferred and stored via secure, encrypted NHS-approved methods and retained in compliance with UK GDPR principles.