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IRCT20260908070967N1 IRCT 2026-09-25 Kermanshah University of Medical Sciences Comparison of the efficacy of vonoprazan and pantoprazole in the prevention of stress ulcers Comparing the Efficacy of Pantoprazole and Vonoprazan for Stress Ulcer Prophylaxis in Critically Patients Admitted to the ICU, a RCT study 2026-11-21 anticipated 88 Pending https://irct.ir/trial/93137 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization Method: Block randomization with variable block sizes (4 and 6). Unit of Randomization: Individual (each patient is allocated separately). The random sequence is generated by R software. Allocation is performed using sequentially numbered, opaque, sealed envelopes. The envelope for each patient is opened only after confirming eligibility and obtaining consent, Blinding description: Eligible patients will be allocated in a 1:1 ratio to either the vonoprazan or pantoprazole group after obtaining informed consent. The randomization sequence will be generated using R software with block randomization, employing variable block sizes of 4 and 6, by a biostatistician who will have no involvement in the study execution. Patient allocation will be performed using sequentially numbered, opaque, sealed envelopes (SNOSE). After verification of eligibility criteria and obtaining consent, the corresponding envelope will be opened by the responsible individual, and the patient will be assigned to one of the two groups. Outcome assessors and the statistical analyst will remain blinded to the intervention type until the completion of the study. Drug type, demographic and clinical data (e.g., APACHE II score at admission), and daily outcomes will be collected solely by a trained researcher/nurse who has no role in the treatment process. Data will be recorded daily at the patient's bedside in the ICU using paper case report forms. 3 Gastric ulcer. Intervention 1: Pantoprazole group: patients receive 40 milligrams of pantoprazole intravenously daily. Administration starts upon intensive care unit admission or initiation of enteral feeding and continues until discharge, initiation of full oral feeding, occurrence of gastrointestinal bleeding, or a maximum of 14 days. Intervention 2: Vonoprazan group: patients receive 20 milligrams of vonoprazan orally via a nasogastric tube daily. Administration starts upon intensive care unit admission or initiation of enteral feeding and continues until discharge, initiation of full oral feeding, occurrence of gastrointestinal bleeding, or a maximum of 14 days. Yes - There is a plan to make this available What will be shared: Participant data file: individual participant data after removal of identifiers, including demographics, intervention group, primary and secondary outcomes, and confounders, shareable upon request by qualified researchers. Study protocol: full version including objectives, methods, inclusion and exclusion criteria, and randomization method. Statistical analysis plan: description of statistical methods, tests, and models used. Informed consent form: the text of the consent form provided to participants and signed by them, without including participants' identifying information. Clinical study report: final report of the study results. Analysis codes: R software codes used for data analysis. Data dictionary: complete definition of all variables and their coding. When: Access to the data and documents begins 6 months after publication of the study results. To whom: Available only to researchers affiliated with academic institutions. Conditions: The data and documents may be used only for research and academic purposes, including secondary analyses, reproduction of results, and meta‑analysis. Commercial use, transfer of data to third parties, and any attempt to identify participants are prohibited. Applicants must submit a written request including the study title, objectives, analysis methods, and list of researchers. The request is accepted after review and approval by the scientific and ethics committee of the study, and upon signing a confidentiality and data use agreement. Results must be reported to the study team after publication. Where to obtain: Applicants can submit their request via email to mjavad.alibakhshi@kums.ac.ir. If needed, correspondence is also possible through the postal address of the Vice Chancellery for Research and Technology, Medical Sciences Building Number 2, Shahid Beheshti Boulevard, Kermanshah, Iran. Responses are provided by the study principal investigator. The first priority for contact is email, followed by postal correspondence. How to obtain: The applicant first submits a written request including the study title, objectives, analysis methods, and list of researchers. The request is reviewed within 7 working days and referred to the scientific and ethics committee of the study for approval. This stage takes about 14 to 21 working days. After approval, a confidentiality and data use agreement is sent to the applicant, and upon signing and returning it, the data or documents are delivered within 7 working days. Overall, the process takes about 4 to 6 weeks. Comments:
public Mohammadjavad Alibakhshi
Imam Reza hospital, Baghabrisham Ave.
Kermanshah Iran (Islamic Republic of) 6742775333 +98 83 3427 6323 mjavad.alibakhshi@kums.ac.ir Kermanshah University of Medical Sciences scientific Mohammadjavad Alibakhshi
Imam Reza hospital, Baghabrisham Ave.
Kermanshah Iran (Islamic Republic of) 6742775333 +98 83 3427 6323 mjavad.alibakhshi@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Admission to the ICU 18 years no limit Both Active gastrointestinal bleeding at admission History of gastric or duodenal surgery altering acid absorption or secretion Use of a proton pump inhibitor, histamine 2 receptor antagonist, or vonoprazan within the past 7 days Known hypersensitivity to any of the study drugs Pregnancy or breastfeeding Severe hepatic failure Impossibility of administering the study drug or withdrawal of the patient or legal guardian K25 Gastric ulcer Prevention Prevention Pantoprazole group: patients receive 40 milligrams of pantoprazole intravenously daily. Administration starts upon intensive care unit admission or initiation of enteral feeding and continues until discharge, initiation of full oral feeding, occurrence of gastrointestinal bleeding, or a maximum of 14 days. Vonoprazan group: patients receive 20 milligrams of vonoprazan orally via a nasogastric tube daily. Administration starts upon intensive care unit admission or initiation of enteral feeding and continues until discharge, initiation of full oral feeding, occurrence of gastrointestinal bleeding, or a maximum of 14 days. Clinically important gastrointestinal bleeding (hematemesis, melena, hematochezia or frank blood in gastric tube with hemodynamic instability or transfusion need). Timepoint: The primary outcome is measured daily from intensive care unit admission until discharge, initiation of full oral feeding, occurrence of bleeding, or a maximum of 14 days. Method of measurement: The primary outcome is measured through daily clinical monitoring and assessment of blood in the gastric tube, hematemesis, melena, or hematochezia, along with recording vital signs, hemoglobin testing, and transfusion need, using a pre‑designed checklist. Overt Gastrointestinal Bleeding without Hemodynamic Instability: Presence of visible evidence of gastrointestinal bleeding including hematemesis, melena, hematochezia, or blood observed in gastric suction or nasogastric tube, without hemodynamic instability. Timepoint: Daily during Intensive Care Unit stay. Method of measurement: Clinical observation of nasogastric tube or gastric suction contents and patient record review by a trained researcher. Ventilator-Associated Pneumonia: Occurrence of pneumonia in a mechanically ventilated patient that develops more than 48 hours after initiation of ventilation. Timepoint: Daily from initiation of mechanical ventilation. Method of measurement: Based on clinical and paraclinical criteria including fever, pulmonary secretions, chest radiography findings, and respiratory culture, recorded by the attending physician. Clostridioides Difficile Infection: Occurrence of Clostridioides difficile-associated diarrhea. Timepoint: Daily during Intensive Care Unit stay. Method of measurement: Patient record review, clinical examination, and laboratory results (toxin test or stool culture). Kermanshah University of Medical Sciences Approved 2026-08-09 Ethics committee of Kermanshah University of Medical Sciences Kermanshah University of Medical Sciences, Bagh Abrisham ave. Kermanshah Kermanshah Iran (Islamic Republic of)