Stress ulcers in ICU patients. Chronic or unspecified gastric ulcer with hemorrhage
Conditions
Interventions
Intervention 1: Intervention group: Vonoprazan 20 mg tablet, administered orally or via nasogastric tube (NGT), once every 24 hours. The drug administration will start upon study enrollment and contin
Sponsors
Semnan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age > 18 years Functional nasogastric tube (NGT) in place Patients requiring stress ulcer prophylaxis with at least one indication: mechanical ventilation > 48 hours, coagulopathy, shock, traumatic brain injury or spinal cord injury, severe burns > 30% body surface area, receiving > 250 mg hydrocortisone/week Informed consent obtained from patient or legally authorized representative
Exclusion criteria
Exclusion criteria: Absolute indications for PPI use including active bleeding, confirmed peptic ulcer, or recent GI bleed admission Ongoing PPI or H2RA treatment within 48 hours prior to enrollment Known contraindications to PPIs or Vonoprazan (allergy, HIV medication use, advanced liver failure) Concurrent use of strong CYP3A4 inducers or inhibitors Concurrent use of antacids or gastric pH altering medications Severe renal or hepatic impairment Pregnancy or lactation Anatomical abnormalities of the stomach Zollinger-Ellison syndrome or other hypersecretory conditions Predicted ICU stay < 72 hours Concurrent participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Gastric pH during the first 72 hours of intervention. Timepoint: Baseline, 3 hours, 5 hours, 24 hours, 48 hours, and 72 hours after the first dose. Method of measurement: Calibrated portable digital pH meter using gastric aspirates from nasogastric tube (NGT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean pH at specific time points (baseline, 3h, 5h, and daily fasting). Timepoint: Baseline, 3 hours, 5 hours, and daily fasting measurements within the first 72 hours. Method of measurement: Calibrated portable digital pH meter using gastric aspirates from nasogastric tube (NGT).;Percentage of samples with pH = 4 during the first 72 hours of intervention. Timepoint: All valid samples collected within the first 72 hours. Method of measurement: Calculated from pH meter readings.;Time-to-first pH = 4. Timepoint: From the start of intervention until the first pH measurement = 4 and sustained in subsequent measurements. Method of measurement: Measured in hours from the start of intervention using gastric aspirates and a calibrated pH meter.;Incidence of clinically significant gastrointestinal bleeding. Timepoint: During the 72-hour intervention period. Method of measurement: Defined as overt bleeding (hematemesis, melena, or NGT bleeding) with hemodynamic instability, need for blood transfusion (=2 units in 24 hours), or hemoglobin drop =2 g/dL. Assessed through clinical observation, medical record review, and lab tests.;Incidence of Ventilator-Associated Pneumonia (VAP). Timepoint: During ICU stay. Method of measurement: Based on standard clinical and radiographic criteria, confirmed by respiratory secretion cultures. Assessed through clinical observation, medical record review, and culture results.;Incidence of Clostridioides difficile infection (CDI). Timepoint: During ICU stay. Method of measurement: Presence of =3 loose stools in 24 hours with a positive C. difficile toxin assay. Assessed through clinical observation, medical record review, and laboratory results.;Length of stay in ICU and hospital. Timepoint: From admission to ICU/hospital discharge. Method of measurement: Number of full days spent from ICU/hospital admission to discharge. Recorded in medical records.;28-day all-cause mortality. Timepoint: Assessed on day 28 after randomization. Method of measureme | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Memarian
Semnan University of Medical Sciences
Outcome results
None listed