The INFECIR-2 Albumin Prevention Study (INFECIR2)
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|ClinicalTrials.gov Identifier: NCT02034279|
Recruitment Status : Terminated (Low recruitment rate and expiration of the study drug)
First Posted : January 13, 2014
Last Update Posted : May 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Chronic Liver Disease Urinary Infection Pneumonia Cholangitis Other Bacterial Diseases||Drug: Albumin||Phase 4|
The aim of this study is to evaluate if IV albumin administration improves short-term survival in patients with advanced cirrhosis (serum creatinine ≥ 1.2 mg/dl, serum sodium ≤ 130 mEq/l -milliequivalents per liter- and/or serum bilirubin ≥4 mg/dl) and bacterial infections other than spontaneous bacterial peritonitis (urinary infection, pneumonia, spontaneous or secondary bacteremia, skin/soft tissue infection, acute cholangitis or suspected bacterial infection).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Albumin Administration in the Prevention of Hepatorenal Syndrome and Death in Patients With Cirrhosis, Bacterial Infections Other Than Spontaneous Bacterial Peritonitis and High Risk of Hospital Mortality|
|Actual Study Start Date :||May 2014|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||February 10, 2017|
Experimental: Intravenous infusion of albumin
Treatment arm will receive intravenous albumin on days 1 and 3 plus antibiotics
Intravenous infusion of 20% albumin
Other Name: Albutein 20 by Grifols
No Intervention: No albumin
- survival [ Time Frame: hospitalization ]Hospital survival will be the primary outcome
- survival [ Time Frame: 28-d and 90-day survival ]Percentage of subjects within each arm that survived at these time points
- Renal dysfunction [ Time Frame: hospitalization (expected average 2 weeks) ]number of participants
- circulatory dysfunction [ Time Frame: day 3 and day of infection resolution ]plasma concentration of hormones
- Inflammation and endothelial function [ Time Frame: day of infection resolution ]Plasma concentration of cytokines
- subsequent organ failure [ Time Frame: hospitalization (expected average 2 weeks) ]number of organ failures
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): NCT02034279
|Barcelona, Spain, 08036|
|Principal Investigator:||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, Aarhus, Denmark|
|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|