Ignite Creation Date:
2024-07-17 @ 11:09 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483737
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-26
Brief Title:
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy HACHE
Sponsor:
General Hospital of Shenyang Military Region
Organization:
General Hospital of Shenyang Military Region
Study Overview
Official Title:
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy HACHE an Invesitgator-initiated Open-label Multicenter Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 23-30gL will be enrolled They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None