Liver cirrhosis MedDRA version: 20.0 Level: LLT Classification code 10001558 Term: Albumin System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Human Albumin 200 g/l solution for infusion (generic as per SmPC)
Product Name: Human Albumin 200 g/l solution for infusion (generic as per SmPC)
Pharmaceutical Form: Solution for infusion
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • All patients admitted to hospital with acute onset or worsening of complications of cirrhosis e.g. alcoholic hepatitis, hepatic encephalopathy, ascites, hepatic hydrothorax, hyperbilirubinaemia, oesophageal variceal bleed, any infection precipitating acute decompensation or any other presentation of acute decompensation / acute onset chronic liver failure • Over 18 years of age • Predicted hospital admission > 5 days at trial enrolment, which must be within 72 hours of admission • Serum albumin =65 years) yes F.1.3.1 Number of subjects for this age range 189
Exclusion criteria
Exclusion criteria: • Advanced hepatocellular carcinoma with life expectancy of less than 8 weeks • Patients who will receive palliative treatment only during their hospital admission • Patients who are pregnant • Severe cardiac dysfunction • Any clinical condition which the investigator considers would make the patient unsuitable for the trial • The patient has been involved in a clinical trial of Investigational Medicinal Products (IMPs) within the previous 30 days (including re-randomisation into the RCT) • Trial investigators unable to identify the patient (by NHS number)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility Trial Primary objective: This is a trial to determine whether it is possible to restore and maintain blood albumin levels to near normal in patients admitted to hospital with complications due to advanced liver disease. The patients will be given repeated doses of 100ml 20% Human Albumin Solution (HAS) straight into their veins. HAS will be prescribed according to the albumin levels in the blood measured by standard blood tests. Randomised Control Trial Primary objective: This is a trial to confirm whether increasing the blood albumin level to near normal in patients admitted to hospital with advanced liver disease using repeated dosing of HAS will reduce chances of the development of hospital-acquired infection, renal dysfunction and death for the treatment period. Patients will be allocated at random to receive either HAS or standard medical care to compare the two treatments. ;Secondary Objective: Feasibility Secondary objectives: We shall look at how well the white blood cells (which fight infection) function in patients while they are in the study. For this study immune suppression will be considered improved by albumin if white blood cell function improves following albumin dosing. Clinical data will be collected on: 1. Safety 2. Rate of infection 3. In-hospital mortality 4. Total amount of fluid given 5. Intensive Care Unit admission 6. Organ dysfunction 7. Duration of hospital stay Patients in the feasibility trial will not be followed up following discharge. Randomised Clinical Trial Secondary objectives: 1. Mortality at 28 days post randomisation and at 3 & 6 months post discharge 2. Time to outcome (first event of infection/organ dysfunction/death) 3. Transplant within six months of treatment 4. Total amount of albumin administered during the treatment period 5. Duration of hospital stay 6. Prognostic sores (predictive scores for liver disease an;Primary end point(s): Feasibility Study: Daily serum albumin level for | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Feasibility Study: Daily Leukocyte Function assessed by our laboratory based leukocyte bioassay. Information will also be collected on: Total volume of albumin infused; Safety; Rate of nosocomial infections; In-hospital mortality; Total amount of fluid administered; ICU admission; Organ dysfunction/prognostic score (UKELD, MELD, Child’s Pugh, CLIF-SOFA scores); Duration of hospital stay. RCT: 1. Mortality at 28 days post randomisation and 3 & 6 months post discharge 2. Time to outcome (first event of infection/organ dysfunction/death) 3. Transplant within six months of trial treatment 4. Total amount of HAS administered during the treatment period 5. Duration of hospital stay 6. Prognostic score (assessed by UKELD, MELD, CPS) at baseline and end of treatment 7. Worst daily NEWS Score during treatment period 8. Incidence of Systemic Inflammatory Response Syndrome (SIRS) during trial intervention period 9. Incidence of Septic Shock during trial treatment period 10. Days in ICU during trial treatment period 11. Incremental cost and cost-effectiveness for up to 6 month post discharge 12. Impact on quality of life for up to 6 month post discharge 13. Safety and tolerability of HAS as indicated by Serious Adverse Events (SAEs) 14. Requirement for nutritional support (nasogastric feed, nutritional supplements or total parenteral nutrition) during the trial treatment period ;Timepoint(s) of evaluation of this end point: For the secondary outcomes, this will be evaluated following intervention period in the feasilibility trial and 6 months following discharge for the RCT. | — |
Countries
United Kingdom
Contacts
Public ContactJames Blackstone
UCL Comprehensive Clincial Trials Unit
Outcome results
None listed