NCT07270874

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: 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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Fundacion Clinic per a la Recerca Biomédica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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).

Conditions

• Decompensated Cirrhosis
• AKI - Acute Kidney Injury

Interventions

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

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-08-01
• Completion: 2028-02-01
• First posted: 2025-12-08
• Last updated: 2025-12-18