Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)
NCT ID: NCT06483737
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
174 participants
INTERVENTIONAL
2025-06-24
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Modified dosage group
Intravenous infusion of human albumin 30-60g.
Human albumin infusion at a modified dosage
Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.
Lactulose
All participants will receive standard treatment of overt HE according to the current practice guideline.
Rifaximin
All participants will receive standard treatment of overt HE according to the current practice guideline.
Ornithine Aspartate
All participants will receive standard treatment of overt HE according to the current practice guideline.
Branched-Chain Amino Acids
All participants will receive standard treatment of overt HE according to the current practice guideline.
Arginine
All participants will receive standard treatment of overt HE according to the current practice guideline.
Routine dosage group
Intravenous infusion of human albumin 10-20g.
Human albumin infusion at a routine dosage
Participants receive intravenous infusion of human albumin according to the current clinical practice.
Lactulose
All participants will receive standard treatment of overt HE according to the current practice guideline.
Rifaximin
All participants will receive standard treatment of overt HE according to the current practice guideline.
Ornithine Aspartate
All participants will receive standard treatment of overt HE according to the current practice guideline.
Branched-Chain Amino Acids
All participants will receive standard treatment of overt HE according to the current practice guideline.
Arginine
All participants will receive standard treatment of overt HE according to the current practice guideline.
Interventions
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Human albumin infusion at a modified dosage
Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.
Human albumin infusion at a routine dosage
Participants receive intravenous infusion of human albumin according to the current clinical practice.
Lactulose
All participants will receive standard treatment of overt HE according to the current practice guideline.
Rifaximin
All participants will receive standard treatment of overt HE according to the current practice guideline.
Ornithine Aspartate
All participants will receive standard treatment of overt HE according to the current practice guideline.
Branched-Chain Amino Acids
All participants will receive standard treatment of overt HE according to the current practice guideline.
Arginine
All participants will receive standard treatment of overt HE according to the current practice guideline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A serum albumin level of 23-30g/L
* Age ≥18 years old
* Sign the informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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General Hospital of Shenyang Military Region
OTHER
Responsible Party
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Xingshun Qi
Director of Department of Gastroenterology
Principal Investigators
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Xingshun Qi
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, General Hospital of Northern Theater Command
Locations
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Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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XHNKKY-OHE-RCT
Identifier Type: -
Identifier Source: org_study_id
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