Actively Recruiting
PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease
Led by Universidad Autonoma de Nuevo Leon · Updated on 2026-05-01
80
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. González" de la Factultad de Medicina, Universidad Autónoma de Nuevo León, Monterrey, Nuevo León, México. 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, bleeding 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/ Pantoprazole 40 mg IV per day until discharge. The primary outcome will represent several morbidity situations in these patients, including Hepatic Encephalopathy grades III and IV, 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.
CONDITIONS
Official Title
PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of cirrhosis
- Variceal bleeding confirmed by endoscopic findings consistent with portal hypertension
- Variceal bleeding with hypovolemic shock allowed
You will not qualify if you...
- Shock of any type other than hypovolemic shock
- Patients without cirrhosis
- Severe hepatic encephalopathy at admission (West Haven grades 3 and 4)
- Hepatorenal syndrome
- Acute-on-chronic liver failure with CLIF-C score greater than 50
- Patients with sepsis
- Patients with spontaneous bacterial peritonitis
- Voluntary withdrawal from the study
- Protocol violations
- Patients in the no-PPI group requiring prolonged mechanical ventilation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario "Jose E. González" de la Facultad de Medicina, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
Research Team
L
Luis A González Torres, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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