descompensated hepatic cirrosis
Conditions
Brief summary
Analyze the effect of HA versus (NaCl 0.9%) administration on the 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 with AKI 1B or higher will be evaluated, defining AKI resolution as the percentage of patients with a decrease in serum creatinine levels < 0.3 mg/dL with respect to baseline serum creatinine, without the need for TRT.
Detailed description
Survival rate at 28 days, considering liver transplantation as a competitive risk event, AKI improvement, defined as the percentage 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, Changes from baseline in systemic inflammatory response, evaluated by measurement in a large array of plasma cytokine levels including, but not limited to TNFα, IL-6, IL8, IL-10, IL-1β, IFN-ɣ, G-CSF, VCAM, VEGF, as well as an oxidized form of albumin, human nonmercaptalbumin-2 (HNA2) at visits 1, 2, 4, 5 and 6, Changes from baseline in different plasma and urine prognostic biomarkers including, but not only, copeptin, NGAL, PD-L1, L-FABP at visits 1, 2, 4, 5 and 6., Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma renin concentration and plasma copeptin at visits 1, 2, 4, 5 and 6,, Changes in echocardiographic parameters (E/E', ITV, among others) at visit 1, 2, 7 and 28., Proportion of patients and severity of treatment-related adverse events during the study period
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analyze the effect of HA versus (NaCl 0.9%) administration on the 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 with AKI 1B or higher will be evaluated, defining AKI resolution as the percentage of patients with a decrease in serum creatinine levels < 0.3 mg/dL with respect to baseline serum creatinine, without the need for TRT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival rate at 28 days, considering liver transplantation as a competitive risk event, AKI improvement, defined as the percentage 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, Changes from baseline in systemic inflammatory response, evaluated by measurement in a large array of plasma cytokine levels including, but not limited to TNFα, IL-6, IL8, IL-10, IL-1β, IFN-ɣ, G-CSF, VCAM, VEGF, as well as an oxidized form of albumin, human nonmercaptalbumin-2 (HNA2) at visits 1, 2, 4, 5 and 6, Changes from baseline in different plasma and urine prognostic biomarkers including, but not only, copeptin, NGAL, PD-L1, L-FABP at visits 1, 2, 4, 5 and 6., Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma renin concentration and plasma copeptin at visits 1, 2, 4, 5 and 6,, Changes in echocardiographic parameters (E/E', | — |
Countries
Spain