]>
IRCT20260226068954N1 IRCT 2026-03-25 Semnan University of Medical Sciences Vonoprazan vs. Pantoprazole for Stress Ulcer Prophylaxis in ICU Patients Comparison of Vonoprazan and Pantoprazole in Achieving Target Gastric pH for the Prevention of Stress Ulcers in the Intensive Care Unit: A Randomized Controlled Trial 2026-05-05 anticipated 40 Complete https://irct.ir/trial/89285 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients will be randomly allocated to the intervention (Vonoprazan) and control (Pantoprazole) groups in a 1:1 ratio using block randomization. The operational steps are as follows: 1. Sequence Generation: An independent researcher, uninvolved in sampling, will generate the random allocation sequence using the Sealed Envelope website (www.sealedenvelope.com) with a block size of 4. 2. Allocation Concealment: The generated codes will be placed inside sequentially numbered, opaque, and sealed envelopes. 3. Implementation: Upon the admission of an eligible patient to the ICU, the researcher will open the envelope in sequential order to determine and assign the patient’s treatment group, Blinding description: This is a single-blind study in which only the data analyst is blinded to the allocated interventions. To ensure the data analyst remains unaware of the treatment groups, the collected data will be coded by another researcher (uninvolved in data analysis) before being handed over. The column containing the actual drug names will be removed, and the groups will be renamed using anonymous codes, such as “Group A” and “Group B”. The data analyst will perform all statistical analyses on these coded groups and will remain completely blinded to which code represents Vonoprazan or Pantoprazole until the final analysis is completed and the results are extracted. 3 Stress ulcers in ICU patients. 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 continue until the last day of admission and discharge from the Intensive Care Unit (ICU). Intervention 2: Control group: Pantoprazole 40 mg vial, administered intravenously (IV), once every 24 hours. The drug administration will start upon study enrollment and continue until the last day of admission and discharge from the Intensive Care Unit (ICU). Yes - There is a plan to make this available What will be shared: Anonymized Individual Participant Data (IPD): All collected participant data after removal of identifying information (e.g., name, national ID, exact date of birth, etc.), including demographic information, physiological parameters (e.g., gastric pH at various time points), clinical outcomes (e.g., GI bleeding, VAP, CDI, length of stay, mortality), and other variables recorded in the Case Report Form (CRF). Study Protocol: The complete version of the study protocol, including details of methodology, inclusion/exclusion criteria, intervention procedures, outcomes, and data analysis methods. Statistical Analysis Plan: A detailed plan of the statistical analyses intended for examining study outcomes and hypotheses. Clinical Study Report: A comprehensive report of the study findings after completion and data analysis. Data Dictionary: A file containing precise definitions of all collected variables, their units of measurement, and coding methods. When: Access Period Start: 6 months after the publication of the study results (journal article print). Access Duration: Data and documents will be available for 10 years from the start of the access period. To whom: Researchers affiliated with accredited academic and scientific institutions, clinicians, and healthcare professionals who present a relevant research proposal and require the data for non-commercial research purposes. Conditions: Purpose: Analysis and examination of primary and secondary study outcomes. Conducting secondary and ancillary studies based on the available data. Validation of the current study's findings. Use in related research projects concerning stress ulcer prophylaxis and gastric acid management in ICU patients. Conditions: Submission of a written request detailing the research plan, objectives, methodology, and data analysis strategy. Completion of a Non-Disclosure Agreement (NDA) and Data Use Agreement. Approval of the research proposal by the Institutional Review Board (IRB) or Ethics Committee of the researcher's institution. Exclusive use for non-commercial research purposes; no redistribution of data to third parties without explicit permission. Proper citation of the original study in all reports and publications derived from this data. Where to obtain: Interested applicants may contact the study's research coordinator via email: Contact Person: Dr. Mohammad Memarian Title: Supervisor, Research Officer Email: aria2018@gmail.com paniz1re@gmail.com Mailing address: Semnan, Golestan Town, Amin Boulevard, Kowsar Hospital Postal Code: 3519899951 How to obtain: 1. Request Submission: The applicant submits a written request along with their research proposal and completed forms (NDA, Data Use Agreement) via email or mail. 2. Request Review: The request is reviewed by the research lead and relevant committee. Upon approval of the research proposal and adherence to the terms, further steps are initiated. (Estimated Review Time: 2-4 weeks) 3. Notification of Decision: The applicant is informed of the decision (approval or rejection). 4. Data/Document Delivery: Upon approval, the data and documents will be securely delivered to the applicant (e.g., via an encrypted download link or secure cloud storage). (Estimated Delivery Time: 1-2 weeks post-approval) Comments: This study was conducted with the aim of advancing scientific knowledge and improving patient care in intensive care units. We are eager to collaborate with other interested researchers to leverage this data for the advancement of scientific research.
public Mohammad Memarian
Basij Boulevard
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3343 7821 aria2018@gmail.com Semnan University of Medical Sciences scientific Hossein Karbalaei
Semnan Department University of Medical Sciences, Basij Boulevard
Semnan Iran (Islamic Republic of) 3519899951 +98 23 3343 7838 Karbalayihossein1363@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 K25.4 Chronic or unspecified gastric ulcer with hemorrhage Treatment - Drugs Treatment - Drugs 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 continue until the last day of admission and discharge from the Intensive Care Unit (ICU). Control group: Pantoprazole 40 mg vial, administered intravenously (IV), once every 24 hours. The drug administration will start upon study enrollment and continue until the last day of admission and discharge from the Intensive Care Unit (ICU). 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). 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 measurement: Patient's survival status (alive or deceased). Assessed through medical records and follow-up contact. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs): Any untoward medical occurrence, including serious events leading to death, hospitalization, disability, or congenital anomaly. Timepoint: Throughout the study duration. Method of measurement: Assessed through clinical observation and medical record review. Semnan University of Medical Sciences Approved 2026-02-16 Research Ethics Committees of Semnan University Of Medical Sciences and Health Services Staff of Semnan University of Medical Sciences and Health Services, Basij Blvd Semnan Semnan Iran (Islamic Republic of)