Acute Liver Failure Clinical Trial
Official title:
Identification of Outcome Biomarkers in Patients With Liver Failure.
Acute liver injury (ALI) and acute liver failure (ALF) are rare clinical conditions, the latter often associated with a poor outcome. To improve outcomes for these patients, clinicians need to develop a clearer understanding of the pathophysiology of this condition. Biomarkers and novel imaging techniques are vital to investigating and understanding the pathophysiology of ALI. Patients with ALI or ALF aged over 16 and due to any cause will be eligible to take part in the study. The study will involve collection of biological samples (blood, urine, stool and breath) from included patients once daily for up to 7 days. For patients undergoing liver transplantation, a small sample of explanted (removed) liver tissue will be obtained. A small subgroup of patients with paracetamol induced acute liver failure will be eligible to be included in a pilot MRI (magnetic resonance imaging) study, which will involve two MRI scans during the first 7 days of their admission. All patients will be recruited from the Royal Infirmary of Edinburgh.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | November 2026 |
Est. primary completion date | October 2026 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 80 Years |
Eligibility |
Inclusion Criteria: - acute liver injury (newly deranged liver function tests (LFTs) and coagulopathy with International Normalized Ratio (INR) >1.5 in absence of chronic liver disease) - acute liver failure ( as above, plus hepatic encephalopathy) - acute on chronic liver failure (worsening of LFTS and development of at least 1 organ failure in patient with cirrhosis) - stable cirrhosis - non-cirrhotic liver disease Exclusion Criteria: - refusal of consent - withdrawal of consent |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | NHS Lothian |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of biomarkers and radiological markers predictive of development of complications and outcomes in acute liver injury and acute liver failure. | 10 years | No | |
Secondary | Identification of proteins involved in the pathogenesis of acute liver injury and acute liver failure | 10 years | No |
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