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Table 2 Primary, secondary and safety endpoints of the trial

From: Stop of proton-pump inhibitor treatment in patients with liver cirrhosis (STOPPIT): study protocol for a prospective, multicentre, controlled, randomized, double-blind trial

Primary composite endpoint

Secondary endpoint

1.) Unplanned re-hospitalization

1.) Death

2.) Death

2.) Unplanned re-hospitalization

 

3.) Any infection and differentiated by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus infection, SARS-CoV-2 infection, others)

 

4.) Acute hepatic decompensation and ACLF

 

5.) Upper or lower gastrointestinal bleeding event

 

Safety endpoint: Evidence based re-therapy with PPI due to the occurrence of any the following conditions:

 

1.) Peptic ulcer diagnosed by EGD

 

2.) Reflux esophagitis LA grade C or D diagnosed by EGD

 

3.) Severe hemorrhagic gastritis diagnosed by EGD and histology

 

4.) Mallory-Weiss syndrome diagnosed by EGD

  1. SBP spontaneous bacterial peritonitis, SARS-CoV-2 severe acute respiratory syndrome coronavirus 2, ACLF acute-on-chronic liver failure, PPI proton-pump inhibitors, EGD oesophago-gastro-duodenoscopy