Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

NCT06483737 | Recruiting

• 1 other identifier: XHNKKY-OHE-RCT
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatic encephalopathy (HE), a severe 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 its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.

Conditions

Overt Hepatic Encephalopathy

Keywords

hepatic encephalopathy; liver cirrhosis; human albumin; inflammation; oxidative stress; survival

Outcome Measures

Primary Outcomes (1)

• Change of overt HE.

  The change of HE is defined as a decrease or an increase of at least one grade of the West Haven criteria after treatment.

  3-5 days

Secondary Outcomes (4)

• Reversal of overt HE.

  3-5 days

• Recurrence of overt HE.

  3 months

• Adverse events

  3 months

• Survival

  3 months

Study Arms (2)

Modified dosage group

EXPERIMENTAL

Intravenous infusion of human albumin 30-60g.

Drug: Human albumin infusion at a modified dosage; Drug: Lactulose; Drug: Rifaximin; Drug: Ornithine Aspartate; Drug: Branched-Chain Amino Acids; Drug: Arginine

Routine dosage group

ACTIVE COMPARATOR

Intravenous infusion of human albumin 10-20g.

Drug: Human albumin infusion at a routine dosage; Drug: Lactulose; Drug: Rifaximin; Drug: Ornithine Aspartate; Drug: Branched-Chain Amino Acids; Drug: Arginine

Interventions

Human albumin infusion at a modified dosage DRUG

Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.

Also known as: AlbuRx

Modified dosage group

Human albumin infusion at a routine dosage DRUG

Participants receive intravenous infusion of human albumin according to the current clinical practice.

Also known as: AlbuRx

Routine dosage group

Lactulose DRUG

All participants will receive standard treatment of overt HE according to the current practice guideline.

Also known as: Duphalac

Modified dosage group; Routine dosage group

Rifaximin DRUG

All participants will receive standard treatment of overt HE according to the current practice guideline.

Also known as: Xifaxan

Modified dosage group; Routine dosage group

Ornithine Aspartate DRUG

All participants will receive standard treatment of overt HE according to the current practice guideline.

Modified dosage group; Routine dosage group

Branched-Chain Amino Acids DRUG

All participants will receive standard treatment of overt HE according to the current practice guideline.

Also known as: Compound amino acid injection

Modified dosage group; Routine dosage group

Arginine DRUG

All participants will receive standard treatment of overt HE according to the current practice guideline.

Also known as: Arginine Hydrochloride Injection

Modified dosage group; Routine dosage group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A definite diagnosis of liver cirrhosis and overt HE
• A serum albumin level of 23-30g/L
• Age ≥18 years old
• Sign the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, China

RECRUITING

Related Publications (6)

• Sharma BC, Singh J, Srivastava S, Sangam A, Mantri AK, Trehanpati N, Sarin SK. Randomized controlled trial comparing lactulose plus albumin versus lactulose alone for treatment of hepatic encephalopathy. J Gastroenterol Hepatol. 2017 Jun;32(6):1234-1239. doi: 10.1111/jgh.13666.

  PMID: 27885712 BACKGROUND

• Simon-Talero M, Garcia-Martinez R, Torrens M, Augustin S, Gomez S, Pereira G, Guevara M, Gines P, Soriano G, Roman E, Sanchez-Delgado J, Ferrer R, Nieto JC, Sunye P, Fuentes I, Esteban R, Cordoba J. Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study. J Hepatol. 2013 Dec;59(6):1184-92. doi: 10.1016/j.jhep.2013.07.020. Epub 2013 Jul 19.

  PMID: 23872605 BACKGROUND

• China L, Freemantle N, Forrest E, Kallis Y, Ryder SD, Wright G, Portal AJ, Becares Salles N, Gilroy DW, O'Brien A; ATTIRE Trial Investigators. A Randomized Trial of Albumin Infusions in Hospitalized Patients with Cirrhosis. N Engl J Med. 2021 Mar 4;384(9):808-817. doi: 10.1056/NEJMoa2022166.

  PMID: 33657293 BACKGROUND

• Bai Z, Bernardi M, Yoshida EM, Li H, Guo X, Mendez-Sanchez N, Li Y, Wang R, Deng J, Qi X. Albumin infusion may decrease the incidence and severity of overt hepatic encephalopathy in liver cirrhosis. Aging (Albany NY). 2019 Oct 8;11(19):8502-8525. doi: 10.18632/aging.102335. Epub 2019 Oct 8.

  PMID: 31596729 BACKGROUND

• Bai Z, Mendez-Sanchez N, Romeiro FG, Mancuso A, Philips CA, Tacke F, Basaranoglu M, Primignani M, Ibrahim M, Wong YJ, Nery FG, Teschke R, Ferreira CN, Munoz AE, Pinyopornpanish K, Thevenot T, Singh SP, Mohanty A, Satapathy SK, Ridola L, Maruyama H, Cholongitas E, Levi Sandri GB, Yang L, Shalimar, Yang Y, Villa E, Krag A, Wong F, Jalan R, O'Brien A, Bernardi M, Qi X; Liver Cirrhosis-related Complications (LCC)-International Special Interest Group. Use of albumin infusion for cirrhosis-related complications: An international position statement. JHEP Rep. 2023 May 5;5(8):100785. doi: 10.1016/j.jhepr.2023.100785. eCollection 2023 Aug.

  PMID: 37456673 BACKGROUND

• Li Q, Tong H, Liu X, Liao F, Ma H, Zhou Z, Liu F, Shi H, Wang Z, Sun Y, Yao Q, Feng Y, Li X, Feng J, He Z, Peng Y, Bai Z, Zhu R, Cheng D, Xu C, He S, Yu H, Xie C, Yuan J, Wang X, Yang H, Zou Y, Li S, Li T, Hu S, Chen C, Chen Z, Lantinga MA, Bernardi M, Qi X, Tang C; On the behalf of Young Member Group of Chinese Gastroenterology Society. Human Albumin infusion in liver Cirrhosis and overt Hepatic Encephalopathy (HACHE): protocol of an investigator-initiated, open-label, multicentre, randomised controlled trial. BMJ Open. 2025 Nov 5;15(11):e094300. doi: 10.1136/bmjopen-2024-094300.

  PMID: 41198206 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy; Liver Cirrhosis; Inflammation

Interventions

Albumins; Lactulose; Rifaximin; ornithylaspartate; Amino Acids, Branched-Chain; Arginine

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Amino Acids; Amino Acids, Basic; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Xingshun Qi

  Department of Gastroenterology, General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingshun Qi

CONTACT

18909881019; xingshunqi@126.com

Qianqian Li

CONTACT

13940307473; 1208594776@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: June 24, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)