CirrhosisPOCUS-CNCT07810855
Using Bedside Ultrasound to Understand Fluid Management in Patients With Chronic Liver Disease
An observational study of Cirrhosis and Ascites Hepatic, run by Royal Free Hospital NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Ascites Hepatic, Fluid Balance
- What is being tested?
- Ultrasound measurement and Blood draw for the laboratory assessment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants must be capable of giving informed consent
- Hospitalized patients with liver cirrhosis (of any cause) and clinically significant ascites
- > 18 years of age
Who cannot join
- patients receiving end of life care
About this study
Official title: POCUS Guided Fluid Resuscitation in Cirrhosis
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:
Read more
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
- Being tested
- Ultrasound measurement, Blood draw for the laboratory assessment
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound measurementDiagnostic 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 assessmentDiagnostic test
A blood sample for research analysis may be taken at the same time as standard of care blood tests during the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success or failure of POCUS readings
The number of POCUS scans attempted that resulted in a recorded measurement
Measured: 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
Measured: 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
Measured: 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
The delta of POCUS readings before and after fluid management interventions (intravenous fluid or albumin, diuretics, terlipressin or large volume paracentesis)
Measured: 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
Measured: 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)
Measured: From enrolment until 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Free Charity
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810855
- Sponsor's protocol ID
- 375050
- Other IDs
- 1325/RD
- Acronym
- POCUS-C
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POCUS Guided Fluid Resuscitation in Cirrhosis
- ClinicalTrials.gov ID
- NCT07810855
- Acronym / sponsor ID
- POCUS-C / 375050
- Conditions
- Cirrhosis, Ascites Hepatic, Fluid Balance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Royal Free Charity
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Participants must be capable of giving informed consent
- Hospitalized patients with liver cirrhosis (of any cause) and clinically significant ascites
- > 18 years of age
Key exclusion criteria (1 listed)
- patients receiving end of life care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound measurementPoint-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. | Diagnostic test | – |
| Blood draw for the laboratory assessmentA blood sample for research analysis may be taken at the same time as standard of care blood tests during the study. | Diagnostic test | – |
Primary outcome
Technical success or failure of POCUS readings
Time frame: From enrollment until the end of the POCUS readings period at 7 days
The number of POCUS scans attempted that resulted in a recorded measurement
Duration of POCUS readings
Time frame: From enrolment until the end of the POCUS readings period at 7 days
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
Patient acceptability
Time frame: From enrollment until the end of the POCUS readings period at 7 days
Structured feedback from participants on the acceptability of the POCUS readings via a questionnaire
3 secondary outcomes
Changes in POCUS measurements in response to fluid management interventions
Time frame: From enrolment until the end of POCUS readings period at 7 days
Correlation of POCUS readings with clinical assessment
Time frame: From enrolment until end of POCUS readings period (7 days)
Correlation of POCUS readings with clinical outcomes
Time frame: From enrolment until 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Ascites Hepatic, run by Royal Free Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success or failure of POCUS readings (time frame: From enrollment until the end of the POCUS readings period at 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.