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
Age ≥ 18 years old.
Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. (Cirrhosis of any etiology may be included).
Patients with AKI 1B or greater, defined according to EASL guidelines (EASL. J Hepatol 2018).
Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence** (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function
Time since AKI diagnosis > 24 hours.
Patients with AKI due to pure hypovolemia. According to guidelines, these patients should receive crystalloid solutions (i.e. NaCl 0.9%) and will be excluded from the study. Fluid losses will be specifically assessed by an accurate anamnesis and physical examination. If patient's diuretic treatment has been increased recently (within prior 2 weeks), or the patient had diarrhea before admission, patient will be considered that the AKI phenotype is pre-renal and will be excluded from the analysis. Patients will be excluded when clear evidence of hypovolemia is present, based on clinical history (e.g, recent fluid losses, diuretic escalation, diarrhea) and corroborating physical findings (e.g, dry mucous membranes, reduced skin turgor, sunken eyes, or low jugular venous pressure)
Patients with AKI due to gastrointestinal bleeding with AKI 1B or greater, and hemoglobin < 7.0 g/dL. These patients can be included after 48 hours without rebleeding and Hb ≥ 8.0 g/dL, and still present AKI 1B or greater.
Patients who had already received albumin at the time of inclusion/exclusion criteria assessment.
Parallel
Saline solution (NaCl 0.9%)
DrugSaline 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.
Survival rate patients
Survival rate patients at 28 days, considering liver transplantation as a competitive risk event.
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.
Proportion of patients requiring RRT In both groups
Proportion of patients requiring RRT In both groups (renal replacemtent theraphy)
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)
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
