Investigating the effects of proton pump inhibitors on patients with variceal bleeding and liver disease
In-Hospital Morbidity Associated With Proton Pump Inhibitors in Acute Variceal Bleeding and Chronic Liver Disease Treatment
This study is testing if giving a medication called omeprazole to adults with liver disease and variceal bleeding can help them have a better recovery while they are in the hospital.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad Autonoma de Nuevo Leon Academic / other |
| Locations | 1 site (Monterrey, Nuevo León) |
| Trial ID | NCT06861478 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the in-hospital morbidity of patients with cirrhosis who present to the emergency department with variceal bleeding. It is a longitudinal, prospective, experimental study conducted at a single center, focusing on adult patients diagnosed with cirrhosis and experiencing variceal bleeding without shock or infection. Participants will receive intravenous omeprazole at a dosage of 40 mg as part of the intervention. The study will exclude patients with certain severe conditions to ensure a focused analysis of the target population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a diagnosis of cirrhosis who present with variceal bleeding and meet specific clinical criteria.
Not a fit: Patients with acute liver failure, septic conditions, or other severe complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve management strategies for patients with cirrhosis experiencing variceal bleeding, potentially reducing morbidity.
How similar studies have performed: While there is ongoing research in this area, the specific approach of using proton pump inhibitors in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Monterrey, Nuevo León
- Hospital Universitario "Jose E. González" de la Facultad de Medicina, Universidad Autónoma de Nuevo León — Monterrey, Nuevo León, Mexico (Recruiting)
Study contacts
- Study coordinator: Luis A González Torres, MD
- Email: Luis37torres@gmail.com
- Phone: +5218116091332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.