Study to Evaluate the Efficacy of Intravenous Administration of Human Albumin Versus Saline Solution in Patients With descompénsate Cirrhosis Grade 1B or Higher Renal Failure

NCT07270874 | Not Yet Recruiting Phase 4

• 1 other identifier: LIVER-AKI
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

AKI - Acute Kidney Injury; Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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.

  at any time during the study (all visits: screenning, basal , day 1, day2, day 5, day 7, day 15, and day 28)

Secondary Outcomes (10)

• Survival rate patients

  at 28 days (visit 6)

• AKI improvement

  basal visit , day 1, day2, day 5, day 7, day 15, and day 28)

• Proportion of patients requiring RRT In both groups

  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)

  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,

  basal visit , day 1, day2, day 5, day 7, day 15, and day 28)

Study Arms (2)

Human Albumin

NO INTERVENTION

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.

Saline solution

EXPERIMENTAL

Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours

Drug: Saline solution (NaCl 0.9%)

Interventions

Saline solution (NaCl 0.9%) DRUG

Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours.

Saline solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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.
• Patients under renal replacement therapy, or with urgent criteria of RRT.
• Patients with hepatocellular carcinoma beyond Milan criteria.
• 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.
• Previous liver and/or kidney transplantation.
• Patients with current extra hepatic malignancies including solid tumors and hematologic disorders.
• 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.
• Refusal to give informed consent.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Ana CRUCETA, Md

CONTACT

+34 932275400; acruceta@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Manager

Model Details: This is a phase IV, unicentric, open-label, randomized clinical trial, low interventional level

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 8, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share