NCT02034279

Brief Summary

The aim of this study is to evaluate whether albumin administration improves short-term survival in patients with advanced cirrhosis and bacterial infections other than Spontaneous Bacterial Peritonitis (SBP).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

January 7, 2014

Last Update Submit

May 17, 2017

Conditions

Advanced Chronic Liver DiseaseUrinary InfectionPneumoniaCholangitisOther Bacterial Diseases

Keywords

cirrhosis

Outcome Measures

Primary Outcomes (1)

  • survival

    Hospital survival will be the primary outcome

    hospitalization

Secondary Outcomes (5)

  • survival

    28-d and 90-day survival

  • Renal dysfunction

    hospitalization (expected average 2 weeks)

  • circulatory dysfunction

    day 3 and day of infection resolution

  • Inflammation and endothelial function

    day of infection resolution

  • subsequent organ failure

    hospitalization (expected average 2 weeks)

Study Arms (2)

Intravenous infusion of albumin

EXPERIMENTAL

Treatment arm will receive intravenous albumin on days 1 and 3 plus antibiotics

Drug: Albumin

No albumin

NO INTERVENTION

Only antibiotics

Interventions

AlbuminDRUG

Intravenous infusion of 20% albumin

Also known as: Albutein 20 by Grifols
Intravenous infusion of albumin

Eligibility Criteria

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

You may qualify if:

  • Cirrhotic patients with age ≥18 years
  • Diagnosis of urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection at hospital admission or during hospitalization
  • Patients with uncomplicated urinary infections or suspected bacterial infection will require the presence of signs of systemic inflammation: at least 1 diagnostic criterion of systemic inflammatory response syndrome (SIRS) and serum CRP levels ≥1 mg/dl (10 mg/L). This criterion will not be required for the rest of infections

You may not qualify if:

  • \> 72h after infection diagnosis
  • Pregnancy
  • Acute or subacute liver failure without underlying cirrhosis
  • Septic shock
  • Severe acute respiratory distress syndrome (Pa02/Fi02 ≤ 100)
  • Active or recent variceal bleeding unless controlled for \> 48h
  • Ongoing type-1 HRS (past IAC criterion: serum creatinine ≥ 2.5 mg/dl)
  • Type-3 ACLF (defined according to the Canonic Study criteria)
  • Hemodialysis or other renal replacement therapy
  • Evidence of current malignancy (except for hepatocellular carcinoma within Milan criteria or non-melanocytic skin cancer)
  • Moderate or severe chronic heart (NYHA class II, III or IV) or pulmonary disease (GOLD IV)
  • Severe psychiatric disorders
  • Previous liver transplantation
  • HIV infection (except for patients under antiretroviral therapy with undetectable viral load, CD4\>200/mm3 and no history of opportunistic infections diagnostic of AIDS)
  • Contraindications to albumin (allergy, signs of pulmonary edema)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (3)

  • Guevara M, Terra C, Nazar A, Sola E, Fernandez J, Pavesi M, Arroyo V, Gines P. Albumin for bacterial infections other than spontaneous bacterial peritonitis in cirrhosis. A randomized, controlled study. J Hepatol. 2012 Oct;57(4):759-65. doi: 10.1016/j.jhep.2012.06.013. Epub 2012 Jun 23.

    PMID: 22732511BACKGROUND

  • Thevenot T, Bureau C, Oberti F, Anty R, Louvet A, Plessier A, Rudler M, Heurgue-Berlot A, Rosa I, Talbodec N, Dao T, Ozenne V, Carbonell N, Causse X, Goria O, Minello A, De Ledinghen V, Amathieu R, Barraud H, Nguyen-Khac E, Becker C, Paupard T, Botta-Fridlung D, Abdelli N, Guillemot F, Monnet E, Di Martino V. Effect of albumin in cirrhotic patients with infection other than spontaneous bacterial peritonitis. A randomized trial. J Hepatol. 2015 Apr;62(4):822-30. doi: 10.1016/j.jhep.2014.11.017. Epub 2014 Nov 21.

    PMID: 25463545BACKGROUND

  • Fernandez J, Angeli P, Trebicka J, Merli M, Gustot T, Alessandria C, Aagaard NK, de Gottardi A, Welzel TM, Gerbes A, Soriano G, Vargas V, Albillos A, Salerno F, Durand F, Banares R, Stauber R, Prado V, Arteaga M, Hernandez-Tejero M, Aziz F, Morando F, Jansen C, Lattanzi B, Moreno C, Campion D, Gronbaek H, Garcia R, Sanchez C, Garcia E, Amoros A, Pavesi M, Claria J, Moreau R, Arroyo V. Efficacy of Albumin Treatment for Patients with Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis. Clin Gastroenterol Hepatol. 2020 Apr;18(4):963-973.e14. doi: 10.1016/j.cgh.2019.07.055. Epub 2019 Aug 5.

    PMID: 31394283DERIVED

Related Links

MeSH Terms

Conditions

Urinary Tract InfectionsPneumoniaCholangitisFibrosis

Interventions

Albumins

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Thierry Gustot

    Erasme University Hospital, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

  • Frederick Nevens

    University Hospitals KU, Leuven, Belgium

    PRINCIPAL INVESTIGATOR

  • Faouzi Saliba

    Hôpital Paul Brousse, Villejuif, France

    PRINCIPAL INVESTIGATOR

  • François Durand

    Hôpital Beaujon, Clichy, France

    PRINCIPAL INVESTIGATOR

  • Matthias Dollinger

    University of Ulm, Heidelberg and Tübingen, Germany

    PRINCIPAL INVESTIGATOR

  • Stefan Zeuzem

    University Hospital of Frankfurt, Germany

    PRINCIPAL INVESTIGATOR

  • Alexander Gerbes

    University Hospital of Munich, Germany

    PRINCIPAL INVESTIGATOR

  • Jonel Trebicka

    University Hospital of Bonn, Germany

    PRINCIPAL INVESTIGATOR

  • Henning Gronbaeck

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Fin Stolze Larsen

    Rigshospitalet, University of Copenhagen

    PRINCIPAL INVESTIGATOR

  • John Willy Haukeland

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

  • Andrea de Gottardi

    Bern University Hospital, Switzerland

    PRINCIPAL INVESTIGATOR

  • Aide McCormick

    University College of Dublin, Ireland

    PRINCIPAL INVESTIGATOR

  • Rajiv Jalan

    University College, London

    PRINCIPAL INVESTIGATOR

  • Marco Domenicali

    Santa Orsola-Malpighi Hospital, Bologna, Italy

    PRINCIPAL INVESTIGATOR

  • Paolo Angeli

    University of Padova, Italy

    PRINCIPAL INVESTIGATOR

  • Carlo Alessandria

    San Giovanni Battista Hospital, University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Francesco Salerno

    Policlinico IRCCS San Donato, University of Milan, Italy

    PRINCIPAL INVESTIGATOR

  • Agustin Albillos

    Hospital Ramon y Cajal, Madrid, Spain

    PRINCIPAL INVESTIGATOR

  • Victor Vargas

    Hospital Vall d'Hebron, Barcelona, Spain

    PRINCIPAL INVESTIGATOR

  • Javier Fernandez

    Hospital Clinic, Barcelona, Spain

    PRINCIPAL INVESTIGATOR

  • German Soriano

    Hospital Santa Creu i Sant Pau, Barcelona, Spain

    PRINCIPAL INVESTIGATOR

  • Rafael Bañares

    Hospital Gregorio Marañon, Madrid, Spain

    PRINCIPAL INVESTIGATOR

  • Jose Luis Montero

    Hospital Reina Sofia, Cordoba, Spain

    PRINCIPAL INVESTIGATOR

  • Manuela Merli

    Sapienza University of Rome, Italy

    PRINCIPAL INVESTIGATOR

  • Minneke Coenraad

    Leiden University Medical Center

    PRINCIPAL INVESTIGATOR

  • Rudolf Stauber

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

  • Wolfgang Vogel

    Medical Hospital Innsbrück

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2014

First Posted

January 13, 2014

Study Start

May 1, 2014

Primary Completion

December 31, 2016

Study Completion

February 10, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations

ES(1)