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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
174
Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.
Participants receive intravenous infusion of human albumin according to the current clinical practice.
All participants will receive standard treatment of overt HE according to the current practice guideline.
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China
RECRUITINGChange 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.
Time frame: 3-5 days
Reversal of overt HE.
The reversal of HE is defined as clinical symptoms of overt HE disappear after treatment.
Time frame: 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.
Time frame: 3 months
Adverse events
Adverse events will be monitored, including allergy, heart failure, pulmonary edema, acute hemolysis, renal dysfunction, and neuropsychiatric abnormalities.
Time frame: 3 months
Survival
All participants will be followed by telephone to record survival status, including the major cause and date of death.
Time frame: 3 months
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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.
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.