PPIs and In-Hospital Morbidity in Acute Variceal Bleeding with Chronic Liver Disease

Last updated: February 28, 2025
Sponsor: Universidad Autonoma de Nuevo Leon
Overall Status: Active - Recruiting

Phase

2

Condition

Hemorrhage

Primary Biliary Cholangitis

Treatment

Omeprazol 40 mg IV

Clinical Study ID

NCT06861478
GA24-00007
  • Ages > 18
  • All Genders

Study Summary

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, 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 40 mg IV per day until discharge. The primary outcome will represent several morbidity situations in these patients, including Hepatic Encephalopathy, 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Adult

  • Cirrhosis

  • Variceal Bleeding with only endoscopic findings consistent with portal hypertensioncomplications

  • Hypovolemic shock and Variceal bleeding

Exclusion

Exclusion Criteria:

  • 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

Elimination Criteria

  • Voluntary removal of the study

  • Patients with confounding endoscopic findings (Erosive esophagitis, peptic ulcers,duodenal ulcers, GAVE, and atrophic gastritis).

Study Design

Total Participants: 182
Treatment Group(s): 1
Primary Treatment: Omeprazol 40 mg IV
Phase: 2
Study Start date:
October 20, 2024
Estimated Completion Date:
September 20, 2026

Connect with a study center

  • Hospital Universitario "Jose E. González" de la Facultad de Medicina, Universidad Autónoma de Nuevo León

    Monterrey, Nuevo León 64460
    Mexico

    Active - Recruiting

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