Loading clinical trials...

The INFECIR-2 Albumin Prevention Study | Clinical Trials | Clareo Health

TERMINATEDPHASE4

The INFECIR-2 Albumin Prevention Study

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

NCT02034279•EASL - CLIF Consortium

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)
+11 more criteria

Locations (1)

Hospital Clinic

Barcelona, Spain

Key Dates

Start Date

May 1, 2014

Primary Completion Date

December 31, 2016

Completion Date

February 10, 2017

Last Updated

May 18, 2017

Enrollment

136

ACTUAL participants

Conditions

Advanced Chronic Liver DiseaseUrinary InfectionPneumoniaCholangitisOther Bacterial Diseases

Interventions

Albumin

DRUG

LSM and SSM for the Diagnosis of CSPH: a Prospective Cohort Study

NCT06181409

Advanced Chronic Liver Disease

View study

RECRUITINGPHASE4

Effect of Acetylcysteine Inhalation on Incidence and Time to Develop Ventilator Associated Pneumonia in Critically Ill Mechanically Ventilated Patients

NCT07409727

Ventilation Acquired Pneumonia

View study

RECRUITINGNA

Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The INFECIR-2 Albumin Prevention Study

Inclusion Criteria

Exclusion Criteria

LSM and SSM for the Diagnosis of CSPH: a Prospective Cohort Study

Effect of Acetylcysteine Inhalation on Incidence and Time to Develop Ventilator Associated Pneumonia in Critically Ill Mechanically Ventilated Patients

Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

Performance of New Diagnostic Methods in Older Adults With Pneumonia

Health Systems and Policy Contexts of Medical Oxygen

High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS