Not Yet RecruitingPhase 4

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

114 participantsStarted 2026-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.
✕. 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.

What they're measuring

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,

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

Trial details

NCT IDNCT07270874

SponsorFundacion Clinic per a la Recerca Biomédica

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Ana CRUCETA, Md

+34 932275400 acruceta@recerca.clinic.cat

View on ClinicalTrials.gov More Decompensated Cirrhosis trials