Ignite Creation Date:
2024-05-06 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05070351
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2021-09-27
Brief Title:
Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Randomized Open-label Trial of Deprescribing Proton Pump Inhibitors to Reduce the Risk of Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt Creation
Status:
RECRUITING
Status Verified Date:
2024-03
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:
A total of 40 patients taking proton pump inhibitors PPIs who undergo transjugular intrahepatic portosystemic shunt TIPS creation as part of routine clinical care will be randomized in 11 fashion to either continue or discontinue their PPIs to determine whether these commonly used gastric acid suppressing agents increase risk of post-TIPS hepatic encephalopathy HE Patients will be assessed for symptoms of minimal HE MHE using the established psychometric hepatic encephalopathy score PHES battery of tests MHE assessment will be conducted at two timepoints at baseline prior to randomization and TIPS creation and approximately 4 weeks after randomization and TIPS creation Stool samples will also be collected at both timepoints to allow characterization of the gastrointestinal GI tract microbiome using 16S rRNA sequencing The pre to post-TIPS change in PHES scores will be compared between patients randomized to continue versus discontinue their PPIs Quality of life QOL will also be assessed Changes in the GI tract microbiome will be analyzed to determine whether this represents a potential biological mechanism linking PPI use with post-TIPS HE
Detailed Description:
None
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