Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06052176
Status:
RECRUITING
Last Update Posted:
2024-01-03
First Post:
2023-09-18
Brief Title:
Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement
Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Organization:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Study Overview
Official Title:
Randomized Clinical Trial in Hepatic Encephalopathy to Study Lasting Cognitive Improvement With Intravenous Albumin
Status:
RECRUITING
Status Verified Date:
2023-12
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:
HEAL-LAST
Brief Summary:
Hypothesis Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended and is due to persistent improvement in inflammatory markers endothelial dysfunction albumin function and gut microbial changes
This will be a single-arm single-blind sequential trial of IV 25 albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life HRQOL testing with each subject acting as their own control
This will be a single-arm single-blind sequential trial of IV 25 albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life HRQOL testing with each subject acting as their own control
Detailed Description:
In outpatients with cirrhosis with prior HE who have cognitive impairment despite adequate therapy how long the impact of albumin lasts and through which potential mechanisms needs to be determined
A prior recent HEAL trial showed that patients with prior HE and current minimal hepatic encephalopathy MHE randomized to albumin experienced significant improvement in cognitive dysfunction and psychosocial quality of life Moreover these improvements persisted a week after the last albumin infusion which was not seen in the placebo group This was accompanied by an improvement in endothelial dysfunction ischemia-modified albumin levels and inflammatory markers that persisted one week even after albumin discontinuation The reported half-life of IV albumin is 2 weeks but the function and the length of time of albumins action in decompensated cirrhosis is lower and further details surrounding albumin pharmacokinetics in this population remain unelucidated The mechanisms and length of time albumins potential improvement for patients with MHE after treatment discontinuation also require continued study
Study design
This will be a single-arm single-blind sequential trial of IV 25 albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life HRQOL testing with each subject acting as their own control
Th order of the albumin and placebo infusion and blind the infusions from the subjects and the assessors of the outcomes will be changed
A prior recent HEAL trial showed that patients with prior HE and current minimal hepatic encephalopathy MHE randomized to albumin experienced significant improvement in cognitive dysfunction and psychosocial quality of life Moreover these improvements persisted a week after the last albumin infusion which was not seen in the placebo group This was accompanied by an improvement in endothelial dysfunction ischemia-modified albumin levels and inflammatory markers that persisted one week even after albumin discontinuation The reported half-life of IV albumin is 2 weeks but the function and the length of time of albumins action in decompensated cirrhosis is lower and further details surrounding albumin pharmacokinetics in this population remain unelucidated The mechanisms and length of time albumins potential improvement for patients with MHE after treatment discontinuation also require continued study
Study design
This will be a single-arm single-blind sequential trial of IV 25 albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life HRQOL testing with each subject acting as their own control
Th order of the albumin and placebo infusion and blind the infusions from the subjects and the assessors of the outcomes will be changed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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