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 (LIVER-AKI)

December 16, 2025 updated by: Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica

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 descompénsate Cirrhosis and AKI 1B or Grater

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a phase IV, unicentric, open-label, randomized clinical 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.

Patients will be randomized to receive (1:1):

  1. 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.
  2. Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours. Patients will be followed up for 28 days since the administration of the treatment (at baseline visit).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. (Cirrhosis of any etiology may be included).
  3. Patients with AKI 1B or greater, defined according to EASL guidelines (EASL. J Hepatol 2018).
  4. 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

Exclusion Criteria:

  1. Time since AKI diagnosis > 24 hours.
  2. 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)
  3. 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.
  4. Patients who had already received albumin at the time of inclusion/exclusion criteria assessment.
  5. 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.
  6. Patients under renal replacement therapy, or with urgent criteria of RRT.
  7. Patients with hepatocellular carcinoma beyond Milan criteria.
  8. 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.
  9. Previous liver and/or kidney transplantation.
  10. Patients with current extra hepatic malignancies including solid tumors and hematologic disorders.
  11. Patients included in other clinical trials in the month before inclusion.
  12. 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.
  13. Refusal to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Human Albumin
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.
Experimental: Saline solution
Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours
Drug: Saline solution (NaCl 0.9%)
Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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,
Time Frame: at any time during the study (all visits: screenning, basal , day 1, day2, day 5, day 7, day 15, and day 28)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival rate patients
Time Frame: at 28 days (visit 6)
Survival rate patients at 28 days, considering liver transplantation as a competitive risk event.
at 28 days (visit 6)
AKI improvement
Time Frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
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.
basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Proportion of patients requiring RRT In both groups
Time Frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Proportion of patients requiring RRT In both groups (renal replacemtent theraphy)
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)
Time Frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
picograms per mililiter (pg/mL)
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,
Time Frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
picograms per mililiter (pg/mL)
basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Changes from baseline inG-CSF
Time Frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
micrograms per kilogram of body weight (mcg/kg)
basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma copeptin
Time Frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28),
ypically range from 1 to 13 pmol/L
basal visit , day 1, day2, day 5, day 7, day 15, and day 28),
Changes from baseline in systemic hemodynamics and vasoactive hormones: plasma renin concentration
Time Frame: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
ng/mL/hr (nanograms per milliliter per hour)
basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Changes in echocardiographic parameters (E/E', ITV, among others) at visit 1, 2, 7 and 28.
Time Frame: basal visit , day 1, day2, day 7, day, and day 28)
(E/E', ITV)
basal visit , day 1, day2, day 7, day, and day 28)
Proportion of patients and severity of treatment-related adverse events during the study period
Time Frame: screening visit,basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
number and description SAEs and SUSARs
screening visit,basal visit , day 1, day2, day 5, day 7, day 15, and day 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion Clinic per a la Recerca Biomédica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LIVER-AKI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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