Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06861478 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: Liver-IMPACT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 12, 2026 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Enrollment reduced: 80 → 60 participants
    • Interventions: Omeprazole/ Pantoprazole 40 mg IV (Drug) to Omeprazole 40 mg IV (Drug), pantoprazole 40 mg iv (Drug)
    v4
  2. Notable Enrollment target: 182 to 80
    • Interventions: Omeprazol 40 mg IV (Drug) to Omeprazole/ Pantoprazole 40 mg IV (Drug)
    • Eligibility criteria expanded, about 7 words
    • Study description expanded, about 1 word
    v3
  3. Minor Study description expanded, about 207 wordsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06861478
Lead Sponsor Universidad Autonoma de Nuevo Leon
Conditions
(from sponsor)
Morbidity
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov