Overt Hepatic Encephalopathy
Conditions
Keywords
hepatic encephalopathy, liver cirrhosis, human albumin, inflammation, oxidative stress, survival
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.
Detailed description
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.
Interventions
DRUGHuman albumin infusion at a modified dosage
Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.
DRUGHuman albumin infusion at a routine dosage
Participants receive intravenous infusion of human albumin according to the current clinical practice.
DRUGLactulose
All participants will receive standard treatment of overt HE according to the current practice guideline.
DRUGRifaximin
All participants will receive standard treatment of overt HE according to the current practice guideline.
DRUGOrnithine Aspartate
All participants will receive standard treatment of overt HE according to the current practice guideline.
All participants will receive standard treatment of overt HE according to the current practice guideline.
DRUGArginine
All participants will receive standard treatment of overt HE according to the current practice guideline.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Reversal of overt HE. | 3-5 days | The reversal of HE is defined as clinical symptoms of overt HE disappear after treatment. |
| 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. |
| Adverse events | 3 months | Adverse events will be monitored, including allergy, heart failure, pulmonary edema, acute hemolysis, renal dysfunction, and neuropsychiatric abnormalities. |
| Survival | 3 months | All participants will be followed by telephone to record survival status, including the major cause and date of death. |
Countries
China
Contacts
Primary ContactXingshun Qi
Backup ContactQianqian Li
Outcome results
None listed