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

NCT06861478 | Recruiting Phase 2 FDA Drug

• 1 other identifier: GA24-00007
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Morbidity

Keywords

Proton Bomb Inhibitors; Variceal Bleeding; Morbidity

Outcome Measures

Primary Outcomes (1)

• 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.

  From the date of randomization until hospital discharge or death, assessed up to 13 weeks.

Secondary Outcomes (10)

• Ocurrence of Hepatic Encefalopathy

  From the date of randomization until hospital discharge or death, assessed up to 13 weeks.

• Ocurrence of Acute Kidney Injury

  From the date of randomization until hospital discharge or death, assessed up to 13 weeks.

• Ocurrence of Shock

  From the date of randomization until hospital discharge or death, assessed up to 13 weeks.

• Ocurrence of Re-bleeding

  From the date of randomization until hospital discharge or death, assessed up to 13 weeks.

• Ocurrence of any kind of Infection

  From the date of randomization until hospital discharge or death, assessed up to 13 weeks.

Study Arms (2)

Omeprazole or Pantoprazole 40 mg IV per day

EXPERIMENTAL

These patients are to receive omeprazole after randomization.

Drug: Omeprazole/ Pantoprazole 40 mg IV

No Proton Bomb Inhibitor

NO INTERVENTION

These patients are not to receive omeprazol after randomization.

Interventions

Omeprazole/ Pantoprazole 40 mg IV DRUG

Daily until discharge

Omeprazole or Pantoprazole 40 mg IV per day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• Cirrhosis
• Variceal Bleeding with only endoscopic findings consistent with portal hypertension complications
• Hypovolemic shock and Variceal bleeding

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead

Study Sites (1)

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

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

MeSH Terms

Interventions

Omeprazole; Pantoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Luis A González Torres, MD

CONTACT

+5218116091332; Luis37torres@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 6, 2025
• Study Start: October 20, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

ME (1)