Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04448028
Status:
RECRUITING
Last Update Posted:
2021-05-06
First Post:
2020-06-23
Brief Title:
Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind Placebo-controlled Trial
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Organization:
Universitätsklinikum Hamburg-Eppendorf
Study Overview
Official Title:
Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind Placebo-controlled Trial
Status:
RECRUITING
Status Verified Date:
2021-05
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:
STOPPIT
Brief Summary:
Proton-pump inhibitors PPI are commonly prescribed in an uncritical manner to patients with liver cirrhosis without a clear evidence-based indication Observational studies suggests that PPI use in cirrhotic patients may be a risk factor for the development of infections especially spontaneous bacterial peritonitis SBP A possible explanation are PPI-associated microbiotic shifts leading to small intestinal bacterial overgrowth with subsequently increased bacterial translocation Furthermore PPI therapy in cirrhotic patients may lead to an increased risk for pneumonia and Clostridium difficile-infections
However the evidence is ambiguous as other published studies found no evidence for an association of PPI use with an increased risk for SBP or pneumonia
Moreover an association between episodes of hepatic encephalopathy and PPI use has been reported
Infections and hepatic encephalopathy may often lead to a hospitalization of cirrhotic patients and PPI use at discharge has also been associated to early re-hospitalization
While some studies found an association of PPI and increased mortality in cirrhotic patients other studies could not observe this association
Thus some of the current evidence suggests an unfavourable risk profile of PPIs in patients with liver cirrhosis However this patient population is considered to be at a high risk of gastrointestinal haemorrhage from peptic ulcers Importantly patients with liver cirrhosis have an increased mortality after peptic ulcer bleeding as compared to patients without cirrhosis Therefore generous PPI use may also have a yet unproven preventive effect against upper gastrointestinal bleeding
The STOPPIT trial is the first prospective randomized controlled double-blind trial investigating the effect of discontinuation of long-term PPI therapy on hospitalized patients with complicated liver cirrhosis with a pre-existing long-term PPI therapy Importantly patients with an evidence-based indication for PPI therapy are excluded from the trial All study participants n476 stop their previous PPI treatment and are then randomized 11 to receive either placebo intervention group or esomeprazole 20mgday control group for 360 days
The primary hypothesis anticipates a delay of re-hospitalisation andor death composite endpoint in patients who discontinue PPI treatment as compared to patients who continue PPI therapy Secondary objectives include the assessment of mortality re-hospitalisation rates infection rates rate of acute hepatic decompensation and ACLF as well as rates of upper and lower gastrointestinal bleeding events in both groups Impact of prolonged or discontinued PPI therapy on the intestinal microbiota and pharmacoeconomics will be studied as a secondary assessment
However the evidence is ambiguous as other published studies found no evidence for an association of PPI use with an increased risk for SBP or pneumonia
Moreover an association between episodes of hepatic encephalopathy and PPI use has been reported
Infections and hepatic encephalopathy may often lead to a hospitalization of cirrhotic patients and PPI use at discharge has also been associated to early re-hospitalization
While some studies found an association of PPI and increased mortality in cirrhotic patients other studies could not observe this association
Thus some of the current evidence suggests an unfavourable risk profile of PPIs in patients with liver cirrhosis However this patient population is considered to be at a high risk of gastrointestinal haemorrhage from peptic ulcers Importantly patients with liver cirrhosis have an increased mortality after peptic ulcer bleeding as compared to patients without cirrhosis Therefore generous PPI use may also have a yet unproven preventive effect against upper gastrointestinal bleeding
The STOPPIT trial is the first prospective randomized controlled double-blind trial investigating the effect of discontinuation of long-term PPI therapy on hospitalized patients with complicated liver cirrhosis with a pre-existing long-term PPI therapy Importantly patients with an evidence-based indication for PPI therapy are excluded from the trial All study participants n476 stop their previous PPI treatment and are then randomized 11 to receive either placebo intervention group or esomeprazole 20mgday control group for 360 days
The primary hypothesis anticipates a delay of re-hospitalisation andor death composite endpoint in patients who discontinue PPI treatment as compared to patients who continue PPI therapy Secondary objectives include the assessment of mortality re-hospitalisation rates infection rates rate of acute hepatic decompensation and ACLF as well as rates of upper and lower gastrointestinal bleeding events in both groups Impact of prolonged or discontinued PPI therapy on the intestinal microbiota and pharmacoeconomics will be studied as a secondary assessment
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-005008-16 | EUDRACT_NUMBER | None | None |
| DRKS00021290 | REGISTRY | None | None |
| U1111-1246-0705 | OTHER | None | None |
| 01KG2004 | OTHER_GRANT | German Federal Ministry of Education and Research | None |