Pneumonia Clinical Trial
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
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).
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.
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