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

ConditionMorbidity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Autonoma de Nuevo Leon

About this trial

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.

Eligibility criteria

Qualifiers

Adult

Cirrhosis

Variceal Bleeding with only endoscopic findings consistent with portal hypertension complications

Hypovolemic shock and Variceal bleeding

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Omeprazole 40 mg IV
  • pantoprazole 40 mg iv

Treatment groups

60 Participants
are divided into 2 treatment groups