Complications of cirrhosis Digestive System
Conditions
Interventions
Current interventions as of 05/02/2025:
Trial Design and methodology of the randomised controlled trial:
1. Phase IIb
2. Open-label: participants and physicians treating the patient will be informed
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 01/05/2025: 1. Adults =18 years and diagnosed with cirrhosis of any aetiology. 2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. However, participants with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid dose for =3-month period before study inclusion (to be recorded on concomitant log). 3. Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure – Acute Decompensation score (CLIF-C AD score) =42 points but =65 points at the time of screening. 4. Hospitalisation for acute decompensation [determined as one or more of the following: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy, spontaneous bacterial peritonitis (SBP) or hepatorenal syndrome – acute kidney injury (HRS-AKI)]. 5. Participants able to give informed consent. _____ Previous inclusion criteria: 1. Adults >= 18 years diagnosed with cirrhosis of any aetiology. 2. Cirrhosis, defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. However, participants with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid dose for >=3-month period before study inclusion. 3. Cirrhosis severity risk defined by the European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) >=45 points but <60 points at the time of screening. 4. Hospitalisation for acute decompensation (determined as one or more of the following: increasing ascites, portal hypertensive-related bleeding, overt hepatic encephalopathy, new infection). 5. Participants who are able to give informed consent.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 01/05/2025: 1. Participants with ACLF grade 2 and above according to the criteria published by Moreau 2. Participants with CLIF-C AD score =66, who have a high mortality similar to ACLF =2 participants 3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent 4. Participants with active hepatocellular carcinoma (HCC) or a history of HCC that is in remission for less than 6 months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria 5. Participants with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV 5, COPD GOLD >2, chronic kidney disease with serum creatinine >2 mg/dL or under renal replacement therapy 6. Participants with documented refractory ascites - added 23/05/2025: on a palliative pathway 7. Participants who are active on the transplant waiting list 8. Participants with current extrahepatic malignancies, including solid tumours and hematologic disorders. 9. Participants with mental incapacity, significant language barrier, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study 10. Participants with active viral infections, or yet to achieve a clear response to anti-viral therapy 11. Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses 12. Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g., participants on an end-of-life palliative care pathway) 13. Participants enrolled in other interventional trials _____ Previous exclusion criteria as of 05/02/2025: 1. Participants with ACLF grade 2 and above according to the criteria published by Moreau. 2. Participants with CLIF-C AD score = 66, who have a high mortality similar to ACLF =2 participants. 3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent. 4. Participants with active hepatocellular carcinoma (HCC) or a history of HCC that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria. 5. Participants with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy. 6. Participants with documented refractory ascites 7. Participants who are active on the transplant waiting list. 8. Participants with current extrahepatic malignancies including solid tumours and hematologic disorders. 9. Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study. 10. Participants with active viral infections, or yet to achieve clear response to anti-viral therapy. 11. Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses. 12. Any other reason that the PI considers would make the participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 05/02/2025: To investigate whether the CirrhoCare management system leads to a reduction in the requirement for hospital intervention from new-liver-related complications (ascites, overt hepatic encephalopathy, infection or portal hypertensive bleeding and renal impairment) over 90 days from randomisation. This will be measured by collecting the data on hospital interventions of patients, (predominantly readmissions) on the CirrhoCare management system arm compared with the standard arm over 90 days from randomisation. _____ Previous primary outcome measure: To investigate whether the CirrhoCare management system leads to a reduction in the requirement for hospital intervention from new-liver-related complications (ascites, overt hepatic encephalopathy, infection or portal hypertensive bleeding and renal impairment) over 12 weeks from randomisation. This will be measured by collecting the data on hospital interventions of patients, (predominantly readmissions) on the CirrhoCare management system arm compared with the standard arm over 12 weeks from randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/02/2025: 1. Determine the effects of the CirrhoCare management system on the liver disease severity as assessed by reduction in CLIF-C AD score, or Model for End-stage Liver. This will be measured using the CLIF-C AD score at baseline and follow-up visits at Day 28, Day 56 and Day 90. 2. Assess healthcare resource use and cost analysis over 90 days from randomisation 3. Assessment of user experience and engagement through questionnaires and interviews 4. Health-related Quality of Life (EQ-5D-5L) and frailty assessment (Liver Frailty Index) at Day 90 5. Mortality (overall survival) over 90 days 6. Length of hospital stay and number of hospital readmissions over 90 days from randomisation 7. Assessment of the effects of the individual components making up the primary outcome measure over 90 days 8. The longitudinal effects of all secondary outcomes will be investigated by using an appropriate model that incorporates the Day 28 and Day 56 visits in addition to the Day 90 visit 9. Assessment of the number of hospital readmissions for a given participant and the length of stay of each hospitalisation, over 90 days of follow-up _____ Previous secondary outcome measures: 1. Determine the effects of the CirrhoCare management system on the liver disease severity as assessed by reduction in CLIF-C AD score, or Model for End-stage Liver. This will be measured using the CLIF-C AD score at baseline and follow-up visits at 4, 8 and 12 weeks. 2. Assess healthcare resource use and cost analysis over 12 weeks from randomisation 3. Assessment of user experience and engagement through questionnaires and interviews 4. Health-related Quality of Life (EQ-5D-5L) and frailty assessment (Liver Frailty Index) at 12 weeks 5. Mortality (overall survival) over 12 weeks 6. Length of hospital stay and number of hospital readmissions over 12 weeks from randomisation 7. Assessment of the effects of the individual components making up the primary outco | — |
Countries
England, United Kingdom
Contacts
Public ContactCirrhoCare Trial
Outcome results
None listed