Cirrhosis, Ascites Hepatic, Fluid Balance
Conditions
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.
Interventions
DIAGNOSTIC_TESTUltrasound measurement
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.
DIAGNOSTIC_TESTBlood draw for the laboratory assessment
A blood sample for research analysis may be taken at the same time as standard of care blood tests during the study.
Sponsors
Royal Free Hospital NHS Foundation Trust
Royal Free Charity
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be capable of giving informed consent * Hospitalized patients with liver cirrhosis (of any cause) and clinically significant ascites * \> 18 years of age
Exclusion criteria
* patients receiving end of life care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success or failure of POCUS readings | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of POCUS readings with clinical assessment | From enrolment until end of POCUS readings period (7 days) | A descriptive analysis of how frequently baseline clinical assessments agreed with POCUS findings suggestive of hypovolaemia or hypervolaemia |
| Changes in POCUS measurements in response to fluid management interventions | From enrolment until the end of POCUS readings period at 7 days | The delta of POCUS readings before and after fluid management interventions (intravenous fluid or albumin, diuretics, terlipressin or large volume paracentesis) |
| Correlation of POCUS readings with clinical outcomes | From enrolment until 90 days | 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) |
Outcome results
None listed