Can a simple protein infusion save kidneys in liver patients?
NCT ID NCT07270874
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two intravenous fluids—human albumin and saline—to see which better resolves acute kidney injury in people with decompensated cirrhosis. About 114 adults with moderate to severe kidney damage will receive either treatment. The goal is to improve kidney function without needing dialysis.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Other studies related to the condition(s) this trial covers.
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