Esomeprazole IV for preventing stress ulcers in ICU patients after surgery
Official title: Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU (EPIC-ICU)
Run by Asian Institute of Gastroenterology, India · NCT07399054 · Data updated 2026-11-12
This study tests whether giving esomeprazole 40 mg IV can prevent stress-related stomach ulcers in adults in the ICU after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Asian Institute of Gastroenterology, India Academic / other |
| Locations | 1 site (Hyderabad, Telangana) |
| Status | Recruiting |
| Started | February 23, 2026 |
| Main results expected | February 23, 2027 |
| Study ends | February 23, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07399054 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 years in the ICU after surgery, not esophagogastric in origin, with an expected ICU stay of at least 72 hours, and able to provide consent.
✕Probably not a fit
Patients with allergy to esomeprazole or its excipients, those needing enteral feeding, very limited survival expected, pregnant or breastfeeding individuals, or those with certain severe comorbidities or recent NSAID/PPI use may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study examines the safety and potential effectiveness of intravenous esomeprazole 40 mg in adult post-surgical ICU patients at risk for stress ulcers and GI bleeding. The trial focuses on those anticipated to stay in the ICU for at least 72 hours, excluding patients with certain conditions or current PPI/NSAID use. Data will be collected on incidence of GI events and tolerability to inform prophylaxis decisions in mechanically ventilated or coagulopathic patients. The investigation builds on prior pharmacokinetic data suggesting esomeprazole may offer superior acid suppression compared with other PPIs.
Why it matters
Potential benefit: If successful, IV esomeprazole could provide effective protection against stress ulcer-related GI bleeding in high-risk ICU patients.
How similar studies have gone: Previous pharmacokinetic and clinical data suggest PPIs like esomeprazole can provide stronger acid suppression and symptom control, supporting potential benefit in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18-75 years admitted to an ICU post-surgery. * Non-esophagogastric post-surgical patients. * An anticipated ICU stay for at least 72 hours. * Willing to provide consent. Exclusion Criteria: * Allergy to the study medications or excipients * Need for enteral feeding * Estimated survival of \<96 hours * Pregnant and breastfeeding females. * History of severe thrombocytopenia, coagulopathy, Child-Pugh Class C liver disease, or organ transplant requiring immunosuppressive therapy. * On other PPIs and/or NSAIDs for last 48 hrs.
Where it's running
-
AIG Hospitals
Hyderabad, Telangana, India Recruiting
Study contacts
- Principal investigator: G V Rao, Mbbs,mams,frcs — Asian Institute Of Gastroenterology Private Limited
- Study coordinator: G V Rao, Mbbs,mams,frcs
- Email: gvraoaig@gmail.com
- Phone: +91-9182645727
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.