PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease
Status:
RECRUITING
Trial end date:
2026-09-20
Target enrollment:
Participant gender:
Summary
With this study, the investigators pretend to describe intrahospital morbidity in patients living with cirrhosis (PLC) who present to the emergency department with variceal bleeding (VB).
This study is a longitudinal, prospective, experimental, analytical single-center clinical trial. The study will be performed in the Hospital Universitario "Jose E. Gonzlez" de la Factultad de Medicina, Universidad Autnoma de Nuevo Len, Monterrey, Nuevo Len, Mxico.
The studied population consists of adult-age patients with previous, recent, or new diagnoses of cirrhosis who present to the ED with VH without shock, infection, or acute or chronic disease with a \<30% probability of death (CLIF-C \<50). The exclusion criteria involve minor age, Acute Liver Failure (ALF), ICU patients, Hepatorenal Syndrome, sepsis or infection, and shock on admission except for hypovolemic and CLIF-C \>50 points. Elimination criteria involve patients who want to discontinue treatment and patients with confounding endoscopic findings (Erosive esophagitis, peptic ulcers, duodenal ulcers, GAVE, and atrophic gastritis).
After the endoscopic intervention, the investigators will propose inclusion. After acceptance with Informed Consent, the investigators will randomize the patients to receive or not receive Omeprazole 40 mg IV per day until discharge. The primary outcome will represent several morbidity situations in these patients, including Hepatic Encephalopathy, intra-hospital infections, re-bleeding, shock, and acute kidney failure.
The secondary outcomes include the individual analysis of each component of our compound primary outcome, mortality by day 30, differences when grouping patients by Child-Pugh stratification, and comparing results in patients receiving omeprazole for more or less than 5 days.