An observational study in Cirrhosis, Ascites Hepatic and Fluid Balance, sponsored by Royal Free Hospital NHS Foundation Trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Royal Free Hospital NHS Foundation Trust · Observational
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.
1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.
This study's planned enrollment of 100 is below the median of 157 across 386 observational studies indexed under Fibrosis.
Browse Fibrosis studies →Royal Free Hospital NHS Foundation Trust is the lead sponsor of 34 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants under the care of the hepatology team at the Royal Free Hospital will be recruited from the emergency department, wards or ambulatory care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
A blood sample for research analysis may be taken at the same time as standard of care blood tests during the study.
Technical success or failure of POCUS readings
The number of POCUS scans attempted that resulted in a recorded measurement
Time frame: 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
Time frame: 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
Time frame: From enrollment until the end of the POCUS readings period at 7 days
Changes in POCUS measurements in response to fluid management interventions
The delta of POCUS readings before and after fluid management interventions (intravenous fluid or albumin, diuretics, terlipressin or large volume paracentesis)
Time frame: From enrolment until the end of POCUS readings period at 7 days
Correlation of POCUS readings with clinical assessment
A descriptive analysis of how frequently baseline clinical assessments agreed with POCUS findings suggestive of hypovolaemia or hypervolaemia
Time frame: From enrolment until end of POCUS readings period (7 days)
Correlation of POCUS readings with clinical outcomes
A descriptive analysis of POCUS parameters and predefined clinical outcomes (emergency readmission to hospital, renal dysfunction, fluid overload/pulmonary oedema, variceal bleeding, hepatic encephalopathy, other organ dysfunction/ACLF grade, ICU admission and death)
Time frame: From enrolment until 90 days
No study locations are listed for this record.
Plan to share: Yes — Only the IPD required to validate the feasibility objectives of this pilot study will be shared with other researchers on request, for valid scientific reasons including inclusion in meta-analyses, validation of the methodology and calculation of effect sizes for future trial design. The consent form for this study allows participants to opt out of data sharing for the purposes of future research.
Supporting information: Study protocol, Informed consent form, Clinical study report
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.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 177 non-industry observational studies under Fibrosis, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 105. This study's planned 5 months is below that.
Counting every sponsor, half of 186 studies reached it within 48 months; a quarter within 21 and three quarters within 105.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Royal Free Hospital NHS Foundation Trust