NCT02034279

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: EASL - CLIF Consortium · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Chronic Liver Disease
• Urinary Infection
• Pneumonia
• Cholangitis
• Other Bacterial Diseases

Interventions

Type	Name	Description
DRUG	Albumin	Intravenous infusion of 20% albumin

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-12-31
• Completion: 2017-02-10
• First posted: 2014-01-13
• Last updated: 2017-05-18

Locations

1 site across 1 country: Spain