A trial to investigate whether giving albumin to patients with advanced liver cirrhosis will reverse immune suppression and improve outcome for infectio
- Conditions
- iver cirrhosisDigestive SystemOther and unspecified cirrhosis of liver
- Registration Number
- ISRCTN14174793
- Lead Sponsor
- niversity College London (UK)
- Brief Summary
2016 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/26810999 protocol 2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30344180 protocol 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28859868 feasibility study results (added 15/11/2019) 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28911947 feasibility study results (added 15/11/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33657293/ results (added 05/03/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34520431/ (added 25/11/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 777
1. 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
2. Over 18 years of age
3. Predicted hospital admission > 5 days at trial enrolment, which must be within 72 hours of admission
4. Serum albumin <30g/l at screening
5. Documented informed consent to participate (or consent given by a legal representative)
1. Advanced hepatocellular carcinoma with life expectancy of less than 8 weeks
2. Patients who will receive palliative treatment only during their hospital admission
3. Pregnancy
4. Known or suspected severe cardiac dysfunction
5. Any clinical condition which the investigator considers would make the patient unsuitable for the trial
6. 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)
7. Trial investigator unable to identify the patient (by NHS number)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method