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

Cirrhosis Clinical Trial

— BETA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02401490
• Other study ID #: BETA
• Secondary ID: 2014-004809-33
• Status: Recruiting
• Phase: Phase 4
• First received: March 24, 2015
• Last updated: December 27, 2017
• Start date: April 2015
• Est. completion date: March 2018

Study information

• Verified date: December 2017
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Joan Genescà Ferrer
• Email: jgenesca[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Cirrhosis
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis

Intervention

Drug:
• Human albumin
1.5gr/Kg/day at least in the 24-48 hours after the hospitalization and 1.0 gr/Kg/day at 72 hours after the first dose.
• Placebo

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona
Spain	Hospital de Sant Joan Despí Moisès Broggi	Sant Joan Despí	Barcelona

Sponsors (2)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation).		90 days
Secondary	Survival at 180 days.		180 days