Study Results
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Basic Information
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TERMINATED
PHASE4
136 participants
INTERVENTIONAL
2014-05-31
2017-02-10
Brief Summary
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Detailed Description
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Primary goals of the study:
• Effect of albumin administration on hospital survival
Secondary goals of the study:
* Effect of albumin administration on 28-day and 90-day survival.
* Effect of albumin administration on the incidence of renal dysfunction, AKI, type-1 and 2 Hepatorenal Syndrome (HRS) during hospitalization.
* Effect of albumin on circulatory function estimated by changes in plasma levels of renin and noradrenaline and in serum levels of lactate among infection diagnosis, day 3 and infection resolution.
* Effect of albumin on serum levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-alpha) and nitric oxide (NOX) and on plasma levels of von Willebrand factor (vWF:Ag) at diagnosis and resolution of infection.
* Effect of albumin on blood leukocyte count and serum C-reactive protein levels (CRP) during infection.
* Effect of albumin on the development of other individual organ failures (renal, liver, cerebral, circulatory, coagulation and respiratory), acute-on-chronic liver failure (ACLF type 1, 2 and 3 according to the Canonic Study), CLIF-SOFA score, CLIF-Consortium score, Child-Pugh score and MELD score during hospitalization.
* Evaluation of predictive factors of HRS and ACLF development in non-SBP infections.
* Samples (blood, plasma, serum and urine) will be obtained and stored for genomic, proteomic and standard biochemical investigations in future ancillary studies related to the aim of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intravenous infusion of albumin
Treatment arm will receive intravenous albumin on days 1 and 3 plus antibiotics
Albumin
Intravenous infusion of 20% albumin
No albumin
Only antibiotics
No interventions assigned to this group
Interventions
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Albumin
Intravenous infusion of 20% albumin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Analytical data of renal and/or liver dysfunction (serum creatinine ≥ 1.2 mg/dl, serum sodium ≤ 130 mEq/l, serum bilirubin ≥4 mg/dl). Patients with pneumonia or documented bacteremia (positive blood cultures) will require the presence of at least 1 of these analytical criteria to be included in the study. Patients with urinary infection, skin/soft tissue infection, acute cholangitis or suspected bacterial infection will require 2 or more criteria for inclusion
Exclusion Criteria
* 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)
* Albumin administration (≥ 80g) in the last 2 days
* Spontaneous bacterial peritonitis coinfection
* Use of any investigational drug within 90 days prior to randomization
* Refusal to participate
* Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent
* Physician and team not committed to intensive care if needed.
18 Years
ALL
No
Sponsors
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EASL - CLIF Consortium
OTHER
Responsible Party
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Principal Investigators
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Thierry Gustot
Role: PRINCIPAL_INVESTIGATOR
Erasme University Hospital, Brussels, Belgium
Frederick Nevens
Role: PRINCIPAL_INVESTIGATOR
University Hospitals KU, Leuven, Belgium
Faouzi Saliba
Role: PRINCIPAL_INVESTIGATOR
Hôpital Paul Brousse, Villejuif, France
François Durand
Role: PRINCIPAL_INVESTIGATOR
Hôpital Beaujon, Clichy, France
Matthias Dollinger
Role: PRINCIPAL_INVESTIGATOR
University of Ulm, Heidelberg and Tübingen, Germany
Stefan Zeuzem
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Frankfurt, Germany
Alexander Gerbes
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Munich, Germany
Jonel Trebicka
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Bonn, Germany
Henning Gronbaeck
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Fin Stolze Larsen
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, University of Copenhagen
John Willy Haukeland
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Andrea de Gottardi
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital, Switzerland
Aide McCormick
Role: PRINCIPAL_INVESTIGATOR
University College of Dublin, Ireland
Rajiv Jalan
Role: PRINCIPAL_INVESTIGATOR
University College, London
Marco Domenicali
Role: PRINCIPAL_INVESTIGATOR
Santa Orsola-Malpighi Hospital, Bologna, Italy
Paolo Angeli
Role: PRINCIPAL_INVESTIGATOR
University of Padova, Italy
Carlo Alessandria
Role: PRINCIPAL_INVESTIGATOR
San Giovanni Battista Hospital, University of Turin, Italy
Francesco Salerno
Role: PRINCIPAL_INVESTIGATOR
Policlinico IRCCS San Donato, University of Milan, Italy
Agustin Albillos
Role: PRINCIPAL_INVESTIGATOR
Hospital Ramon y Cajal, Madrid, Spain
Victor Vargas
Role: PRINCIPAL_INVESTIGATOR
Hospital Vall d'Hebron, Barcelona, Spain
Javier Fernandez
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic, Barcelona, Spain
German Soriano
Role: PRINCIPAL_INVESTIGATOR
Hospital Santa Creu i Sant Pau, Barcelona, Spain
Rafael Bañares
Role: PRINCIPAL_INVESTIGATOR
Hospital Gregorio Marañon, Madrid, Spain
Jose Luis Montero
Role: PRINCIPAL_INVESTIGATOR
Hospital Reina Sofia, Cordoba, Spain
Manuela Merli
Role: PRINCIPAL_INVESTIGATOR
Sapienza University of Rome, Italy
Minneke Coenraad
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Rudolf Stauber
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Wolfgang Vogel
Role: PRINCIPAL_INVESTIGATOR
Medical Hospital Innsbrück
Locations
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Hospital Clinic
Barcelona, , Spain
Countries
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References
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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.
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.
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.
Related Links
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Web page of the INFECIR-2 RCT
Other Identifiers
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2013-002416-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INFECIR 2
Identifier Type: -
Identifier Source: org_study_id
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