This is a phase IV, unicentric, open-label. Patients eligible for this study will be patients with AKI 1B or greater and decompensated cirrhosis from the hospital participating in the study
This is a phase IV, unicentric, open-label, randomized clinical trial to evaluate the efficacy of intravenous human albumin administration versus saline solution (NaCl 0.9%) in patients with decompensated cirrhosis and AKI 1B or grater. Patients will be randomized to receive (1:1): 1. Intravenous Human Albumin 20% (20 g/100 ml), at a dose of 1 g per kg body weight with a maximum of 100 g per day, during 48 hours. 2. Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours. Patients will be followed up for 28 days since the administration of the treatment (at baseline visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours.
probability of AKI resolution among patients with decompensated cirrhosis and AKI 1B or greater acute kidney injury (AKI) clinical efficacy of HA versus saline (NaCl 0.9%) administration in patients will be evaluated,
defining AKI resolution as the proportion of patients with a decrease in serum creatinine levels \< 0.3 mg/dL with respect to baseline serum creatinine, without the need for TRT.
Time frame: at any time during the study (all visits: screenning, basal , day 1, day2, day 5, day 7, day 15, and day 28)
Survival rate patients
Survival rate patients at 28 days, considering liver transplantation as a competitive risk event.
Time frame: at 28 days (visit 6)
AKI improvement
defined as the proportion of patients who decrease at least 1 grade of AKI classification (from 3 to 2, from 2 to 1B, and from 1B to 1A or recovery), without the need for RRT.
Time frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Proportion of patients requiring RRT In both groups
Proportion of patients requiring RRT In both groups (renal replacemtent theraphy)
Time frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Changes from baseline in systemic inflammatory response, evaluated by measurement in a large array of plasma cytokine levels (IL-6, IL8, IL-10, IL-1β)
picograms per mililiter (pg/mL)
Time frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Changes from baseline in systemic inflammatory response, evaluated by measurement in TNFα,
picograms per mililiter (pg/mL)
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Time frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Changes from baseline inG-CSF
micrograms per kilogram of body weight (mcg/kg)
Time frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma copeptin
ypically range from 1 to 13 pmol/L
Time frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28),
Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma renin concentration
ng/mL/hr (nanograms per milliliter per hour)
Time frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Changes in echocardiographic parameters (E/E', ITV, among others) at visit 1, 2, 7 and 28.
(E/E', ITV)
Time frame: basal visit , day 1, day2, day 7, day, and day 28)
Proportion of patients and severity of treatment-related adverse events during the study period
number and description SAEs and SUSARs
Time frame: screening visit,basal visit , day 1, day2, day 5, day 7, day 15, and day 28)