NCT Number: NCT07810855
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
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
Time frame: 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)
Time frame: 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
Time frame: 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)
Royal Free Hospital NHS Foundation Trust
Other
POCUS Guided Fluid Resuscitation in Cirrhosis
Acronym: POCUS-C
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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