An observational study in Stress Ulcers and Reflux Episodes, sponsored by Asian Institute of Gastroenterology, India. Recruiting at 1 site in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Asian Institute of Gastroenterology, India · 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
Comparative 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
Esomeprazole, a PPI, has demonstrated robust efficacy in the management of gastroesophageal reflux disease (GERD).4 An intravenous (IV) formulation has been developed to facilitate administration in patients for whom oral therapy is not feasible. A study assessed the safety profile after 1 and 4 weeks, as well as the efficacy after 4 weeks of treatment with esomeprazole 40 mg once daily. Their findings indicated that esomeprazole, administered either as an IV bolus, IV infusion, or orally for 1 week followed by 3 weeks of oral dosing, was well tolerated and effectively promoted mucosal healing.5 Similarly, another studyreported significant improvements in symptom control, with mean reductions in heartburn (91.6%), acid regurgitation (96%), belching (96.8%), epigastric pain (88.4%), and dysphagia (84.7%). Based on both investigator and patient global assessments, 89.2% of cases were rated as having an excellent to good therapeutic response.6
Comparative 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
In view of this evidence, the present study was designed to evaluate the efficacy of IV esomeprazole for intragastric pH control in post-surgical patients admitted to the ICU, as well as to assess its safety and tolerability in this population
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This study's planned enrollment of 50 is below the median of 1,119 across 23 observational studies indexed under Duodenal Ulcer.
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Exclusion Criteria:
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Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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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.
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.
Proportion of time intragastric pH ≥4 during the 72 hours post dosing
Proportion of time intragastric pH ≥4 during the 72 hours post dosing
Time frame: From enrollment to the end of treatment at 72 hours
• To assess the safety and tolerability of IV Esomeprazole in this patient population, including the incidence of stress ulcers and reflux episodes.
• Incidence of stress ulcers and reflux episodes with the help of Proportion of time intragastric pH \> 5 and \> 6 and Mean intragastric pH on days 1, 2, and 3 post dosing (0-24, 0-48, and 48-72 hrs.)
Time frame: From enrollment to the end of treatment at 72 hours
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Asian Institute of Gastroenterology, India →