Using Bedside Ultrasound to Understand Fluid Management in Patients With Chronic Liver Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Free Hospital NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must be capable of giving informed consent
Hospitalized patients with liver cirrhosis (of any cause) and clinically significant ascites
> 18 years of age
Disqualifiers
patients receiving end of life care
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound measurement
Diagnostic testPoint-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 testA blood sample for research analysis may be taken at the same time as standard of care blood tests during the study.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 days2
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 days3
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 daysSecondary outcomes
1
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 days2
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)3
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 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Royal Free Hospital NHS Foundation Trust
Lead sponsor
Royal Free Charity
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: