Human serum albumin for Decompensated hepatic cirrhosis | Acute kidney injury (AKI)

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years old."}
• {"criterion_text":"- Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. (Cirrhosis of any etiology may be included)."}
• {"criterion_text":"- Patients with AKI 1B or greater, defined according to EASL guidelines (EASL. J Hepatol 2018)."}
• {"criterion_text":"- 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. * A woman will be considered of childbearing potential, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as 0 menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient. ** Sexual abstinence should only be used as a contraceptive method if it is in line with the subjects’ usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, postovulation methods) is not an acceptable method of contraception"}

Exclusion criteria

• {"criterion_text":"- Time since AKI diagnosis > 24 hours."}
• {"criterion_text":"- Patients with AKI due to fluid loss. 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. 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients who had already received albumin at the time of inclusion/exclusion criteria assessment"}
• {"criterion_text":"- Patients with Chronic kidney disease grade 3a or higher, defined as glomerular filtration rate <60ml/min for three months and markers of kidney damage (one or more): Albuminuria (Albumin excretion rate > 30 mg/24h; Albumin-to-creatinine ratio > 30 mg/g), Urine sediment abnormalities, Electrolyte and other abnormalities due to tubular disorders, Abnormalities detected by histology or Structural abnormalities detected by imaging"}
• {"criterion_text":"- Patients under renal replacement therapy, or with urgent criteria of RRT."}
• {"criterion_text":"- Patients with hepatocellular carcinoma beyond Milan criteria."}
• {"criterion_text":"- Patients with severe extrahepatic comorbidities, including congestive heart failure New York Heart Association Grade III/IV, chronic obstructive pulmonary disease Global Initiative for Chronic Obstructive Lung Disease group 2 or higher."}
• {"criterion_text":"- Previous liver and/or kidney transplantation"}
• {"criterion_text":"- Patients with current extra hepatic malignancies including solid tumors and hematologic disorders."}
• {"criterion_text":"- Patients included in other clinical trials in the month before inclusion"}
• {"criterion_text":"- Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study."}
• {"criterion_text":"- Refusal to give informed consent"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"AKI resolution defined 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 renal replacement therapy (TRT)."}

Secondary endpoints

• {"endpoint_text":"- Survival rate at 28 days, considering liver transplantation as a competitive risk event","definition_or_measurement_approach":"Survival status assessed at 28 days; liver transplantation considered as a competing risk in analysis."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"AKI improvement = percentage of patients with at least one-grade decrease in AKI classification without need for renal replacement therapy."}
• {"endpoint_text":"- Proportion of patients requiring RRT In both groups","definition_or_measurement_approach":"Proportion of patients in each arm who require renal replacement therapy during the study period."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Serial plasma cytokine and HNA2 measurements at visits 1, 2, 4, 5 and 6 to assess changes from baseline."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Serial plasma and urine biomarker measurements (copeptin, NGAL, PD-L1, L-FABP, etc.) at visits 1,2,4,5,6 to assess changes from baseline."}
• {"endpoint_text":"- Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma renin concentration and plasma copeptin at visits 1, 2, 4, 5 and 6,","definition_or_measurement_approach":"Serial measurements of systemic hemodynamic parameters and plasma renin and copeptin at visits 1,2,4,5,6 to assess changes from baseline."}
• {"endpoint_text":"- Changes in echocardiographic parameters (E/E', ITV, among others) at visit 1, 2, 7 and 28.","definition_or_measurement_approach":"Echocardiographic assessment (E/E', ITV, others) at visits 1,2,7 and 28 to evaluate changes from baseline."}
• {"endpoint_text":"- Proportion of patients and severity of treatment-related adverse events during the study period","definition_or_measurement_approach":"Assessment of treatment-related adverse events reported during study period, summarized as proportion of patients affected and severity grading."}

Spain

Earliest CTIS Part Ii Submission Date

23-09-2025

Latest Decision Or Authorization Date

29-10-2025

Processing Time Days

36

Number Of Sites

1

Number Of Participants

114

Primary sponsor

Full Name

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

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain