Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy (BETA)

Vall d'Hebron University Hospital (HUVH)

Status and phase: Unknown; Phase 4

Conditions: Hepatic Encephalopathy; Cirrhosis

Treatments: Drug: Human albumin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02401490

2014-004809-33 (EudraCT Number)

BETA

Details and patient eligibility

About

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).

Full description

To evaluate whether albumin administration after an episode of hepatic encephalopathy (≥ grade II) 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).

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups, including a placebo group

Human albumin

Active Comparator group

Description:

human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose.

Treatment:

Drug: Human albumin

placebo

Placebo Comparator group

Description:

saline serum 0.9%

Treatment:

Drug: Placebo