NCT00886925

Brief Summary

The purpose of this study is to determine whether the administration of albumin in addition to the standard care is effective in the treatment of an episode of hepatic encephalopathy in patients with cirrhosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2009

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 17, 2012

Status Verified

April 1, 2012

Enrollment Period

3.3 years

First QC Date

April 22, 2009

Last Update Submit

December 14, 2012

Conditions

Hepatic Encephalopathy

Keywords

Hepatic encephalopathyCirrhosisAlbumin

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients without hepatic encephalopathy

    Day 3

Secondary Outcomes (1)

  • Severity of encephalopathy assessed by CHESS and West-Haven

    Admission to the hospital (up to day 14)

Study Arms (2)

Albumin

ACTIVE COMPARATOR
Drug: Albumin

Saline

PLACEBO COMPARATOR
Drug: Sodium chloride 0.9%

Interventions

AlbuminDRUG

Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.

Albumin
Sodium chloride 0.9%DRUG

Day 0: 400-600 ml. Day 2: 200-400 ml.

Saline

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis of the liver
  • Hepatic encephalopathy stage\>1
  • Completion of a standardized protocol to investigate precipitating factors
  • Informed consent by next of keen

You may not qualify if:

  • Pregnancy
  • Terminal liver disease (advanced liver disease and performance status 3-4 prior to the episode of acute encephalopathy)
  • Need of advanced life support (mechanical ventilation, ionotropic support, dialysis)
  • Need of albumin administration (e.g. bacterial spontaneous peritonitis)
  • Contraindication for albumin administration (e.g. cardiac failure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Parc Tauli

Sabadell, Barcelona, Spain

Location

Hospital de Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (1)

  • Simon-Talero M, Garcia-Martinez R, Torrens M, Augustin S, Gomez S, Pereira G, Guevara M, Gines P, Soriano G, Roman E, Sanchez-Delgado J, Ferrer R, Nieto JC, Sunye P, Fuentes I, Esteban R, Cordoba J. Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study. J Hepatol. 2013 Dec;59(6):1184-92. doi: 10.1016/j.jhep.2013.07.020. Epub 2013 Jul 19.

    PMID: 23872605DERIVED

MeSH Terms

Conditions

Hepatic EncephalopathyFibrosis

Interventions

AlbuminsSodium Chloride

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Juan Cordoba, MD

    Hospital Vall d'Hebron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 23, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 17, 2012

Record last verified: 2012-04

Locations

ES(4)