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The INFECIR-2 Albumin Prevention Study (INFECIR2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
EASL - CLIF Consortium

Tracking Information
First Submitted Date  ICMJE January 7, 2014
First Posted Date  ICMJE January 13, 2014
Last Update Posted Date May 18, 2017
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
survival [ Time Frame: hospitalization ]
Hospital survival will be the primary outcome
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
survival [ Time Frame: 28-day survival ]
28-day survival and in hospital survival (expected average 2 weeks) will be the primary outcome
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2014)
  • survival [ Time Frame: 90-day survival ]
    Percentage of subjects within each arm that survived at this time point
  • 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 citokines
  • subsequent organ failure [ Time Frame: hospitalization (expected average 2 weeks) ]
    number of organ failures
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The INFECIR-2 Albumin Prevention Study
Official Title  ICMJE 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
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).
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Chronic Liver Disease
  • Urinary Infection
  • Pneumonia
  • Cholangitis
  • Other Bacterial Diseases
Intervention  ICMJE Drug: Albumin
Intravenous infusion of 20% albumin
Other Name: Albutein 20 by Grifols
Study Arms  ICMJE
  • Experimental: Intravenous infusion of albumin
    Treatment arm will receive intravenous albumin on days 1 and 3 plus antibiotics
    Intervention: Drug: Albumin
  • No Intervention: No albumin
    Only antibiotics
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 17, 2017)
136
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2014)
512
Actual Study Completion Date  ICMJE February 10, 2017
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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:

  • > 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)
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02034279
Other Study ID Numbers  ICMJE INFECIR 2
2013-002416-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Undecided yet
Responsible Party EASL - CLIF Consortium
Study Sponsor  ICMJE EASL - CLIF Consortium
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account EASL - CLIF Consortium
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP