Investigating the effects of proton pump inhibitors on patients with variceal bleeding and liver disease
Official title: In-Hospital Morbidity Associated With Proton Pump Inhibitors in Acute Variceal Bleeding and Chronic Liver Disease Treatment
Run by Universidad Autonoma de Nuevo Leon · NCT06861478 · Data updated 2026-11-12
This study is testing if giving a medication called omeprazole to adults with liver disease and variceal bleeding can help them have a better recovery while they are in the hospital.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Universidad Autonoma de Nuevo Leon Academic / other |
| Locations | 1 site (Monterrey, Nuevo León) |
| Status | Recruiting |
| Started | October 20, 2024 |
| Main results expected | August 30, 2026 |
| Study ends | September 20, 2026 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT06861478 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with a diagnosis of cirrhosis who present with variceal bleeding and meet specific clinical criteria.
✕Probably not a fit
Patients with acute liver failure, septic conditions, or other severe complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the in-hospital morbidity of patients with cirrhosis who present to the emergency department with variceal bleeding. It is a longitudinal, prospective, experimental study conducted at a single center, focusing on adult patients diagnosed with cirrhosis and experiencing variceal bleeding without shock or infection. Participants will receive intravenous omeprazole at a dosage of 40 mg as part of the intervention. The study will exclude patients with certain severe conditions to ensure a focused analysis of the target population.
Why it matters
Potential benefit: If successful, this study could improve management strategies for patients with cirrhosis experiencing variceal bleeding, potentially reducing morbidity.
How similar studies have gone: While there is ongoing research in this area, the specific approach of using proton pump inhibitors in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Adult * Cirrhosis * Variceal Bleeding with only endoscopic findings consistent with portal hypertension complications * Hypovolemic shock and Variceal bleeding Exclusion Criteria: * Shock of any type other than hypovolemic. * No cirrhotic patients * Patients that have severe Hepatic Encephalopathy at admission (West Haven 3 and 4) * Hepatorenal syndrome * Acute on chronic with CLIF-C \>50 points * Septic patients * Spontaneous Bacterial Peritonitis Elimination Criteria * Voluntary removal of the study * Violation of the study protocol * Patients in the no PBI group that need prolonged mecánica ventilación.
Where it's running
-
Hospital Universitario "Jose E. González" de la Facultad de Medicina, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, Mexico Recruiting
Study contacts
- Study coordinator: Luis A González Torres, MD
- Email: Luis37torres@gmail.com
- Phone: +5218116091332
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.