NCT02401490

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hepatic Encephalopathy
• Cirrhosis

Interventions

Type	Name	Description
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.
DRUG	Placebo

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-03-27
• Last updated: 2017-12-28

Locations

7 sites across 1 country: Spain