MedPath

A trial to investigate whether giving albumin to patients with advanced liver cirrhosis will reverse immune suppression and improve outcome for infectio

Phase 2
Completed
Conditions
iver cirrhosis
Digestive System
Other 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
Inclusion Criteria

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)

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath