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

Phase 4

• Conditions: Cirrhosis; Hepatic Encephalopathy
• Interventions: Drug: Placebo; Drug: Human albumin

• Registration Number: NCT02401490
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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).

Study Timeline

• Study First Submitted: 2015-03-24
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Study Start: 2015-04
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-28
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	saline serum 0.9%
Human albumin	Human albumin	human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose.

Primary Outcome Measures

Name	Time	Method
Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).	90 days

Secondary Outcome Measures

Name	Time	Method
Survival at 180 days.	180 days

Trial Locations

Locations (7)

Corporació Sanitària Parc Taulí; 🇪🇸 Sabadell, Barcelona, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital de Sant Joan Despí Moisès Broggi; 🇪🇸 Sant Joan Despí, Barcelona, Spain