[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623624":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":10,"responsibleParty":30,"collaborators":10,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":10,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":10,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":10,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":10},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Prospective Observational Cohort - Post-surgical ICU Patients",null,"Eligible post-surgical ICU patients will be enrolled into a single prospective observational cohort after providing written informed consent. All patients will receive Esomeprazole 40 mg intravenous as part of routine post-operative ICU care. Gastric pH impedance monitoring, endoscopic evaluations, and clinical assessments will be performed at predefined time points to observe gastric acid control, reflux parameters, safety, and tolerability. No randomization, blinding, or comparator group is involved.",[13],"Drug: Esomeprazole",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Esomeprazole","Esomeprazole 40 mg IV will be administered following extubation (\\~12 hours post-surgery) and subsequently at 24-hour intervals (Day 2 and Day 3) as per routine ICU clinical practice. The drug is not assigned for research purposes but is prescribed as standard care. The study will only observe and record gastric pH parameters, reflux episodes, endoscopic findings, safety, and tolerability.",[9],[21],{"name":22,"affiliation":23,"role":24},"G V RAO, MBBS,MAMS,FRCS","Asian Institute Of Gastroenterology Private Limited","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":10,"email":29},"CONTACT","+91-9182645727","gvraoaig@gmail.com",{"type":24,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Mohan Ramchandani","Consultant Gastroenterology","100623624","efficacy-and-safety-of-esomeprazole-40-mg-iv-in-post-surgical-patients-admitted-to-the-icu-100623624",false,"NCT07399054","Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU","Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU (EPIC-ICU)","Inclusion Criteria:\n\n* Adult patients aged 18-75 years admitted to an ICU post-surgery.\n* Non-esophagogastric post-surgical patients.\n* An anticipated ICU stay for at least 72 hours.\n* Willing to provide consent.\n\nExclusion Criteria:\n\n* Allergy to the study medications or excipients\n* Need for enteral feeding\n* Estimated survival of \\\u003C96 hours\n* Pregnant and breastfeeding females.\n* History of severe thrombocytopenia, coagulopathy, Child-Pugh Class C liver disease, or organ transplant requiring immunosuppressive therapy.\n* On other PPIs and\u002For NSAIDs for last 48 hrs.","ALL","18 Years","75 Years",{"count":44,"type":45},50,"ESTIMATED","OBSERVATIONAL","Critically ill patients admitted to intensive care units (ICUs) are predisposed to upper gastrointestinal (GI) bleeding secondary to stress-related mucosal damage. The two most significant independent risk factors for stress ulceration and subsequent GI bleeding in this setting are mechanical ventilation and coagulopathy.1,2 Observational data indicate that proton pump inhibitors (PPIs) remain the most frequently employed prophylactic agents in the ICU.3\n\nComparative studies evaluating the efficacy of PPIs have shown a positive correlation between their pharmacokinetic properties and acid-suppressive activity. Among available PPIs, esomeprazole demonstrates superior pharmacokinetic characteristics, translating into more effective acid control in clinical use.7,8 In fact, one study reported that the area under the curve (AUC) for esomeprazole was nearly twice that of omeprazole at equivalent doses (14), supporting its enhanced acid-suppressive effect and prolonged maintenance of intragastric pH \\> 4.9",[49,50],"Stress Ulcers","Reflux Episodes","NOT_YET_RECRUITING","2026-02-05",{"date":54,"type":55},"2026-02-10","ACTUAL",{"date":57,"type":45},"2026-01-15",{"date":59,"type":45},"2027-02-28",{"name":5,"class":6}]