Last updated 18 days ago

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
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