Clinical trial NCT06861478: PPIs and In-Hospital Morbidity in Acute Variceal Bleeding with Chronic Liver Disease
Official title: In-Hospital Morbidity Associated with Proton Pump Inhibitors in Acute Variceal Bleeding and Chronic Liver Disease Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Morbidity
Keywords: Proton Bomb Inhibitors
Variceal Bleeding
Morbidity
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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 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 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).

Primary outcomes:
measure: Morbidity
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Secondary outcomes:
measure: Ocurrence of Hepatic Encefalopathy
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
measure: Ocurrence of Acute Kidney Injury
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
measure: Ocurrence of Shock
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
measure: Ocurrence of Re-bleeding
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
measure: Ocurrence of any kind of Infection
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
measure: In-Hospital Mortality
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
measure: Omeprazol <or>5 days morbidity
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
measure: 30 day Mortality
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
measure: 60 day Mortality
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
measure: 90 day Mortality
timeFrame: From the date of randomization until hospital discharge or death, assessed up to 13 weeks.
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "Jose E. González" de la Facultad de Medicina, Universidad Autónoma de Nuevo León
state: Nuevo León
Study officials:
References: