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

NCT02401490 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-12-28

No results posted yet for this study

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).

Conditions

  • Hepatic Encephalopathy
  • Cirrhosis

Interventions

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

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • German Soriano · Hospital de la Santa creu i Sant Pau - Barcelona

  • Jordi Sanchez · Corporació Sanitària Parc Taulí, Sabadell

  • Helena Masnou · Hospital Universitari Germans Trias i Pujol, Badalona

  • Núria Cañete · Hospital del Mar

  • Marta Martín · Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí

  • Elsa Solà · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02401490 on ClinicalTrials.gov