Clinical trial NCT02401490: Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
Official title: Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Cirrhosis
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2015-03-27
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).
timeFrame: 90 days
Secondary outcomes:
measure: Survival at 180 days.
timeFrame: 180 days
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Sabadell
country: Spain
facility: Corporació Sanitària Parc Taulí
state: Barcelona
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hospital de la Santa creu i Sant Pau - Barcelona
name: German Soriano
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporació Sanitària Parc Taulí, Sabadell
name: Jordi Sanchez
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Germans Trias i Pujol, Badalona
name: Helena Masnou
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital del Mar
name: Núria Cañete
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí
name: Marta Martín
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Elsa Solà
role: PRINCIPAL_INVESTIGATOR
References: