Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)
- Conditions
- Overt Hepatic Encephalopathy
- Interventions
- Drug: Human albumin infusion at a modified dosageDrug: Human albumin infusion at a routine dosageDrug: Branched-Chain Amino Acids
- Registration Number
- NCT06483737
- Lead Sponsor
- General Hospital of Shenyang Military Region
- Brief Summary
Hepatic encephalopathy (HE), a fatal complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but the optimal dosage is obscure. Herein, a randomized controlled trial (RCT) aims to compare the efficacy of human albumin infusion at different dosages in cirrhotic patients with overt HE.
- Detailed Description
Overall, 174 cirrhotic patients with a diagnosis of overt HE and a serum albumin level of 23-32g/L will be enrolled. They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. The primary endpoint is the improvement of overt HE within 5 days after treatment. The secondary endpoints include recurrence of overt HE, survival, and adverse events.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 174
- A definite diagnosis of liver cirrhosis and overt HE
- A serum albumin level of 23-32g/L
- Age ≥18 years old
- Sign the informed consent
- Contraindications to human albumin infusion
- A history of transjugular intrahepatic portosystemic shunt
- A diagnosis of acute liver failure
- Severe heart and/or lung diseases
- Psychiatric or nervous diseases
- Pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Modified dosage group Human albumin infusion at a modified dosage Intravenous infusion of human albumin 30-60g. Modified dosage group Lactulose Intravenous infusion of human albumin 30-60g. Modified dosage group Rifaximin Intravenous infusion of human albumin 30-60g. Modified dosage group Ornithine Aspartate Intravenous infusion of human albumin 30-60g. Modified dosage group Branched-Chain Amino Acids Intravenous infusion of human albumin 30-60g. Modified dosage group Arginine Intravenous infusion of human albumin 30-60g. Routine dosage group Human albumin infusion at a routine dosage Intravenous infusion of human albumin 10-20g. Routine dosage group Lactulose Intravenous infusion of human albumin 10-20g. Routine dosage group Rifaximin Intravenous infusion of human albumin 10-20g. Routine dosage group Ornithine Aspartate Intravenous infusion of human albumin 10-20g. Routine dosage group Branched-Chain Amino Acids Intravenous infusion of human albumin 10-20g. Routine dosage group Arginine Intravenous infusion of human albumin 10-20g.
- Primary Outcome Measures
Name Time Method Change of overt HE. 3-5 days The change of HE is defined as a decrease or an increase of at least one grade of the West Haven criteria after treatment.
- Secondary Outcome Measures
Name Time Method Survival 3 months All participants will be followed by telephone to record survival status, including the major cause and date of death.
Recurrence of overt HE. 3 months Clinical symptoms related to overt HE recur and can be diagnosed with overt HE again according to the West Haven criteria.
Reversal of overt HE. 3-5 days The reversal of HE is defined as clinical symptoms of overt HE disappear after treatment.
Adverse events 3 months Adverse events will be monitored, including allergy, heart failure, pulmonary edema, acute hemolysis, renal dysfunction, and neuropsychiatric abnormalities.
Trial Locations
- Locations (1)
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
🇨🇳Shenyang, Liaoning, China