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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.
Overall, 174 patients with a diagnosis of liver cirrhosis, overt HE, and a serum albumin level of 23-30g/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 3-5 days after treatment. The secondary endpoints include recurrence of overt HE, survival, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified dosage group | Experimental | Intravenous infusion of human albumin 30-60g. |
|
| Routine dosage group | Active Comparator | Intravenous infusion of human albumin 10-20g. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human albumin infusion at a modified dosage | Drug | Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of overt HE. | The reversal of HE is defined as clinical symptoms of overt HE disappear after treatment. | 3-5 days |
| Recurrence of overt HE. | Clinical symptoms related to overt HE recur and can be diagnosed with overt HE again according to the West Haven criteria. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingshun Qi | Contact | 18909881019 | xingshunqi@126.com | |
| Qianqian Li | Contact | 13940307473 | 1208594776@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xingshun Qi | Department of Gastroenterology, General Hospital of Northern Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) | Recruiting | Shenyang | Liaoning | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37456673 | 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. | |
| 27885712 |
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|
| Human albumin infusion at a routine dosage | Drug | Participants receive intravenous infusion of human albumin according to the current clinical practice. |
|
|
| Lactulose | Drug | All participants will receive standard treatment of overt HE according to the current practice guideline. |
|
|
| Rifaximin | Drug | All participants will receive standard treatment of overt HE according to the current practice guideline. |
|
|
| Ornithine Aspartate | Drug | All participants will receive standard treatment of overt HE according to the current practice guideline. |
|
| Branched-Chain Amino Acids | Drug | All participants will receive standard treatment of overt HE according to the current practice guideline. |
|
|
| Arginine | Drug | All participants will receive standard treatment of overt HE according to the current practice guideline. |
|
|
| 3 months |
| Adverse events | Adverse events will be monitored, including allergy, heart failure, pulmonary edema, acute hemolysis, renal dysfunction, and neuropsychiatric abnormalities. | 3 months |
| Survival | All participants will be followed by telephone to record survival status, including the major cause and date of death. | 3 months |
|
| Result |
| 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. |
| 23872605 | Result | 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. |
| 33657293 | Result | 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. |
| 31596729 | Result | 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. |
| 41198206 | Derived | 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. |
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D008103 | Liver Cirrhosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| D007792 | Lactulose |
| D000078262 | Rifaximin |
| C002939 | ornithylaspartate |
| D000597 | Amino Acids, Branched-Chain |
| D001120 | Arginine |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000596 | Amino Acids |
| D024361 | Amino Acids, Basic |
| D000599 | Amino Acids, Diamino |
| D000601 | Amino Acids, Essential |
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