Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06861478

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Morbidity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Monterrey, Nuevo León, 64460, Mexico

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omeprazole 40 mg IV

Drug

Daily until discharge

pantoprazole 40 mg iv

Drug

Daily until discharge if omeprazole is unavailable.

Primary outcomes

  1. Morbidity

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

    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.

Secondary outcomes

  1. Ocurrence of Hepatic Encefalopathy

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

    Binary outcome yes/ no

  2. Ocurrence of Acute Kidney Injury

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

    Acute Kidney Failure binary yes/no

  3. Ocurrence of Shock

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

    All types of shock except hypovolemic

  4. Ocurrence of Re-bleeding

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

    Re-bleeding after endoscopic intervention

  5. Ocurrence of any kind of Infection

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

    Infections after randomization

  6. In-Hospital Mortality

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

    The investigators will assess Mortality during hospitalization

  7. Omeprazol <or>5 days morbidity

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

    Patients who received more than or less than 5 days of omeprazole during hospitalization and morbidity

  8. 30 day Mortality

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

    The investigators will assess mortality by day 30, independently of admission status.

  9. 60 day Mortality

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

    The investigators will assess mortality by day 60, independently of admission status.

  10. 90 day Mortality

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

    The investigators will assess mortality by day 60, independently of admission status.

Study contacts

Contact information is provided by the study sponsor or research team.

Luis A González Torres, MD

CONTACT

[email protected]

+5218116091332

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Registry information

Official study title

In-Hospital Morbidity Associated With Proton Pump Inhibitors in Acute Variceal Bleeding and Chronic Liver Disease Treatment

Acronym: Liver-IMPACT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.