Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

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.

More Morbidity trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorUniversidad Autonoma de Nuevo Leon
Academic / other
Locations1 site (Monterrey, Nuevo León)
StatusRecruiting
StartedOctober 20, 2024
Main results expectedAugust 30, 2026
Study endsSeptember 20, 2026
Registry record updatedJune 12, 2026
Trial IDNCT06861478 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.