PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease
182 patients around the world
Available in Mexico
This is a prospective, randomized, and blinded study designed to assess the impact of
proton pump inhibitor (PPI) use on in-hospital morbidity during acute variceal bleeding
in patients with chronic liver disease. The clinical rationale emerges from ongoing
debate regarding the safety and utility of acid suppression therapy in this population,
particularly during hospitalization for portal hypertension-related bleeding.
Following initial stabilization and confirmation of upper gastrointestinal bleeding,
patients undergo diagnostic endoscopy. Upon identification of varices or portal
hypertensive gastropathy, eligible individuals are randomized to either continue
omeprazole (40 mg daily) or discontinue PPI therapy. Randomization is conducted using
computer software, and allocation concealment is maintained from the principal
investigator.
Standard care protocols-including administration of vasoactive agents, prophylactic
antibiotics, and endoscopic therapy-remain unaltered. The only experimental intervention
involves PPI exposure during hospitalization. Clinical, biochemical, and radiological
data are collected systematically throughout the hospital stay. In patients presenting
with ascites, diagnostic paracentesis is performed as indicated. Events including
infection, renal dysfunction, rebleeding, encephalopathy, and circulatory failure are
monitored until discharge.
This study is being conducted at a tertiary university hospital with advanced endoscopy
and critical care infrastructure. Institutional review board approval has been obtained.
Written informed consent is obtained from each participant or their legal representative
prior to enrollment.
Universidad Autonoma de Nuevo Leon
1Research sites
182Patients around the world
This study is for people with
Cirrhosis
Vascular Disorders of the Esophagus
Bleeding Esophageal Varices
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Adult.
Cirrhosis.
Variceal Bleeding with only endoscopic findings consistent with portal hypertension complications.
Hypovolemic shock and Variceal bleeding.
Shock of any type other than hypovolemic.
No cirrhotic patients.
Patients that have Hepatic Encephalopathy at admission.
Hepatorenal syndrome.
Acute on chronic with CLIF-C >50 points.
Septic patients.
Spontaneous Bacterial Peritonitis.
Voluntary removal of the study
Patients with confounding endoscopic findings (Erosive esophagitis, peptic ulcers, duodenal ulcers, GAVE, and atrophic gastritis).
Sites
Hospital Universitario Dr. José Eleuterio González
Recruiting
Av. Dr. José Eleuterio González, Mitras Centro, 64460 Monterrey, N.L., Mexico