Albumin infusion effects in patients with cirrhosis hepatic encephalopathy

Phase 1

• Conditions: hepatic encephalopathty; MedDRA version: 17.1Level: LLTClassification code 10019642Term: Hepatic cirrhosis NOSSystem Organ Class: 100000004871; MedDRA version: 17.1Level: PTClassification code 10019660Term: Hepatic encephalopathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-004809-33-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-12
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 140

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

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>- to evaluate the effects of albumin on hepatic encephalopathy recurrence during the study period. <br>- To analyze whether albumin administration reduces hospitalization requirement. <br>- To study the effects of albumin on circulatory dysfunction index (mean arterial pressure, renal function, plasma vasopressor hormones). <br>- 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 Outcome Measures

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