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

NCT07399054 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-08-26

No results posted yet for this study

Summary

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

Conditions

  • Stress Ulcers
  • Reflux Episodes

Interventions

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.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • G V RAO, MBBS,MAMS,FRCS · Asian Institute Of Gastroenterology Private Limited

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-23
Primary Completion
2027-02-28
Completion
2027-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07399054 on ClinicalTrials.gov