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LIVER AKI: A randomized, open-label 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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521457-16-00
Acronym
LIVER-AKI
Enrollment
114
Registered
2025-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

descompensated hepatic cirrosis

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

DRUGSODIUM CHLORIDE

Sponsors

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026