A Phase 2 interventional study of Omeprazole 40 mg IV and pantoprazole 40 mg iv in Morbidity, sponsored by Universidad Autonoma de Nuevo Leon. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Universidad Autonoma de Nuevo Leon · Phase 2, Interventional, and Treatment
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.
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/ pantoprazole (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 is the lead sponsor of 53 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Elimination Criteria
These patients are to receive omeprazole or pantoprazole after randomization.
Drug: Omeprazole 40 mg IV · Drug: pantoprazole 40 mg iv
These patients are not to receive omeprazol after randomization.
Daily until discharge
Daily until discharge if omeprazole is unavailable.
Morbidity
The primary outcome is a composite dichotomous outcome represented by morbidity situations, including Hepatic Encephalopathy, intra-hospital infections, re-bleeding, shock, and acute kidney failure.
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Hepatic Encefalopathy
Binary outcome yes/ no
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Acute Kidney Injury
Acute Kidney Failure binary yes/no
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Shock
All types of shock except hypovolemic
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of Re-bleeding
Re-bleeding after endoscopic intervention
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Ocurrence of any kind of Infection
Infections after randomization
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
In-Hospital Mortality
The investigators will assess Mortality during hospitalization
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Omeprazol <or>5 days morbidity
Patients who received more than or less than 5 days of omeprazole during hospitalization and morbidity
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
30 day Mortality
The investigators will assess mortality by day 30, independently of admission status.
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
60 day Mortality
The investigators will assess mortality by day 60, independently of admission status.
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
90 day Mortality
The investigators will assess mortality by day 60, independently of admission status.
Time frame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Plan to share: Undecided — The investigators will decide after the finishing of this work
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Aug 2026, 22 months after the start.
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Studies of the drugs tested here: Omeprazole · Pantoprazole
Universidad Autonoma de Nuevo Leon