Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU

Starting soon

Conditions studied: Stress Ulcers, Reflux Episodes

In brief

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

Key facts

Study ID

NCT07399054

Run by

Asian Institute of Gastroenterology, India

People needed

50

Starts

2026-01-15

Expected to finish

2027-02-28

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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