Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborator: Instituto de Salud Carlos III

Criteria

Inclusion Criteria:

1. Age between 18 and 85 years.

2. Liver cirrhosis defined by previous clinical data or liver biopsy.

3. Presence of an episode of acute hepatic encephalopathy of grade> 2.

4. Sign the informed consent

Exclusion Criteria:

1. Pregnant or breast-feeding.

2. Terminal illness.

3. Presence of Acute-on-chronic liver failure.

4. Needing for intensive support measures.

5. Active gastrointestinal bleeding.

6. neurological or psychiatric comorbidity that hinders the assessment of hepatic encephalopathy.

7. Clinical situations in which it is contraindicated to administer intravenous albumin.

8. MELD score less than 15 or greater than 25 at the time of inclusion

9. Any medical condition previous to patient inclusion in the study involving administration of albumin during a previous 7 day period.