Decompensated CirrhosisPhase 4LIVER-AKINCT07270874
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
A Phase 4 study testing Saline solution (NaCl 0.9%) in people with Decompensated Cirrhosis and AKI - Acute Kidney Injury, run by Fundacion Clinic per a la Recerca Biomédica.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis, AKI - Acute Kidney Injury
- What is being tested?
- Saline solution (NaCl 0.9%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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
Who cannot join
- 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 who had already received albumin at the time of inclusion/exclusion criteria assessment.
- 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.
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- 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 included in other clinical trials in the month before inclusion.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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):
- 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 (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).
- Conditions
- Decompensated Cirrhosis, AKI - Acute Kidney Injury
- Being tested
- Saline solution (NaCl 0.9%)
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline solution (NaCl 0.9%)Drug
Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Saline solution (NaCl 0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Survival rate patients at 28 days, considering liver transplantation as a competitive risk event.
Measured: at 28 days (visit 6)
AKI improvement
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.
Measured: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Proportion of patients requiring RRT In both groups
Proportion of patients requiring RRT In both groups (renal replacemtent theraphy)
Measured: 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)
picograms per mililiter (pg/mL)
Measured: 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,
picograms per mililiter (pg/mL)
Measured: basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Changes from baseline inG-CSF
micrograms per kilogram of body weight (mcg/kg)
Measured: 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
ypically range from 1 to 13 pmol/L
Measured: 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
ng/mL/hr (nanograms per milliliter per hour)
Measured: 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.
(E/E', ITV)
Measured: 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
number and description SAEs and SUSARs
Measured: screening visit,basal visit , day 1, day2, day 5, day 7, day 15, and day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase IV, unicentric, open-label, randomized clinical trial, low interventional level
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270874
- Sponsor's protocol ID
- LIVER-AKI
- Acronym
- LIVER-AKI
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07270874
- Acronym / sponsor ID
- LIVER-AKI / LIVER-AKI
- Conditions
- Decompensated Cirrhosis, AKI - Acute Kidney Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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):
- 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 (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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a phase IV, unicentric, open-label, randomized clinical trial, low interventional level
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Saline solution (NaCl 0.9%)Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
- 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
Key exclusion criteria (13 listed)
- 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 who had already received albumin at the time of inclusion/exclusion criteria assessment.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline solution (NaCl 0.9%)Saline solution (NaCl 0.9%) 500 ml every 24 hours, administered during 48 hours. | Drug | Saline solution |
Primary outcome
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.
10 secondary outcomes
Survival rate patients
Time frame: at 28 days (visit 6)
AKI improvement
Time frame: 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)
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)
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)
Changes from baseline inG-CSF
Time frame: 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),
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline solution (NaCl 0.9%) in people with Decompensated Cirrhosis and AKI - Acute Kidney Injury, run by Fundacion Clinic per a la Recerca Biomédica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana CRUCETA, Md (+34 932275400, acruceta@recerca.clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.