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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult

• Cirrhosis

• Variceal Bleeding with only endoscopic findings consistent with portal hypertension complications

• Hypovolemic shock and Variceal bleeding

Locations
Other Locations
Mexico
Hospital Universitario Jose E. González de la Facultad de Medicina, Universidad Autónoma de Nuevo León
RECRUITING
Monterrey
Contact Information
Primary
Luis A González Torres, MD
Luis37torres@gmail.com
+5218116091332
Time Frame
Start Date: 2024-10-20
Estimated Completion Date: 2026-09-20
Participants
Target number of participants: 182
Treatments
Experimental: Omeprazol 40 mg IV per day
These patients are to receive omeprazole after randomization.
No_intervention: No omeprazol
These patients are not to receive omeprazol after randomization.
Sponsors
Leads: Universidad Autonoma de Nuevo Leon

This content was sourced from clinicaltrials.gov