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Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy (BETA)

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ClinicalTrials.gov Identifier: NCT02401490
Recruitment Status : Recruiting
First Posted : March 27, 2015
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief 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).

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Cirrhosis Drug: Human albumin Drug: Placebo Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Albumin Infusion Effects in Mortality in Patients With Cirrhosis and Hepatic Encephalopathy
Study Start Date : April 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018


Arm Intervention/treatment
Active Comparator: Human albumin
human albumin in the 24-48 hours after the hospitalization and at 48+/- 24 hours after the first dose.
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 Comparator: placebo
saline serum 0.9%
Drug: Placebo



Primary Outcome Measures :
  1. Survival at 90 days. (The mortality endpoint is treated as a composite endpoint mortality and / or liver transplantation). [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Survival at 180 days. [ Time Frame: 180 days ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401490


Contacts
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Contact: Joan Genescà Ferrer jgenesca@vhebron.net
Contact: Inmaculada Fuentes Camps, MD 934894113 ext 4881 usic@vhir.org

Locations
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Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain
Principal Investigator: Helena Masnou, MD PhD         
Corporació Sanitària Parc Taulí Recruiting
Sabadell, Barcelona, Spain
Principal Investigator: Jordi Sánchez, MD         
Hospital de Sant Joan Despí Moisès Broggi Recruiting
Sant Joan Despí, Barcelona, Spain
Principal Investigator: Marta Martín, MD PhD         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Joan Genescà, MD PhD         
Sub-Investigator: Meritxell Ventura, MD         
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain
Principal Investigator: Elsa Solà, MD PhD         
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Principal Investigator: German Soriano, MD PhD         
Hospital del Mar Recruiting
Barcelona, Spain
Principal Investigator: Nuria Cañete, MD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Instituto de Salud Carlos III
Investigators
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Principal Investigator: German Soriano Hospital de la Santa Creu i Sant Pau. Barcelona
Principal Investigator: Jordi Sanchez Corporació Sanitària Parc Taulí, Sabadell
Principal Investigator: Helena Masnou Hospital Universitari Germans Trias i Pujol, Badalona
Principal Investigator: Núria Cañete Hospital del Mar
Principal Investigator: Marta Martín Hospital de Sant Joan Despí Moisès Broggi, Sant Joan Despí
Principal Investigator: Elsa Solà Hospital Clinic of Barcelona

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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02401490     History of Changes
Other Study ID Numbers: BETA
2014-004809-33 ( EudraCT Number )
First Posted: March 27, 2015    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Brain Diseases
Hepatic Encephalopathy
Pathologic Processes
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases