Albumin infusion effects in patients with cirrhosis hepatic encephalopathy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004809-33-ES

Enrollment

140

Registered

2015-01-12

Start date

2015-03-09

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatic encephalopathty MedDRA version: 17.1 Level: LLT Classification code 10019642 Term: Hepatic cirrhosis NOS System Organ Class: 100000004871 MedDRA version: 17.1 Level: PT Classification code 10019660 Term: Hepatic encephalopathy System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Albúmina Humana Grifols al 20% Product Name: Albúmina humana al 20% Pharmaceutical Form: Solution for infusion INN or Proposed INN: ALBUMIN CAS Number: 70024-90-7 Other descriptive name: A

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether albumin administration after an episode of hepatic encephalopathy improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).;Secondary Objective: -To evaluate whether albumin administration after an episode of hepatic encephalopathy improves survival at 30, 90 and 180 days. - to evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period. - To analyze whether albumin administration reduces hospitalization requirement. - To study the effects of albumin on circulatory dysfunction index (mean arterial pressure, renal function, plasma vasopressor hormones). - Establishing a serum bank for biochemical and genetic studies related to the pathophysiology of hepatic encephalopathy.;Primary end point(s): Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).;Timepoint(s) of evaluation of this end point: 90 days	—

Measure

Time frame

Main Objective: To assess whether albumin administration after an episode of hepatic encephalopathy improves survival at 90 days (mortality endpoint treated as a composite endpoint death and/ or liver transplantation).;Secondary Objective: -To evaluate whether albumin administration after an episode of hepatic encephalopathy improves survival at 30, 90 and 180 days. - to evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period. - To analyze whether albumin administration reduces hospitalization requirement. - To study the effects of albumin on circulatory dysfunction index (mean arterial pressure, renal function, plasma vasopressor hormones). - Establishing a serum bank for biochemical and genetic studies related to the pathophysiology of hepatic encephalopathy.;Primary end point(s): Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).;Timepoint(s) of evaluation of this end point: 90 days

—

Secondary

Measure	Time frame
Secondary end point(s): - To evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period. - To analyze whether albumin administration reduces hospitalization requirement. - Survival at 180 days.;Timepoint(s) of evaluation of this end point: 180 days	—

Countries

Spain

Contacts

Public ContactInmaculada Fuentes

Unitat de Suport a la Investigació Clínica (USIC)

usic@vhir.org

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026