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

NCT07399054 | Not Yet Recruiting DMC

• 1 other identifier: EPIC-ICU
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of time intragastric pH ≥4 during the 72 hours post dosing

  Proportion of time intragastric pH ≥4 during the 72 hours post dosing

  From enrollment to the end of treatment at 72 hours

Secondary Outcomes (1)

• • To assess the safety and tolerability of IV Esomeprazole in this patient population, including the incidence of stress ulcers and reflux episodes.

  From enrollment to the end of treatment at 72 hours

Study Arms (1)

Single Prospective Observational Cohort - Post-surgical ICU Patients

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

Interventions

Esomeprazole DRUG

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.

Single Prospective Observational Cohort - Post-surgical ICU Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

50

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.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

MeSH Terms

Conditions

Duodenal Ulcer

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• G V RAO, MBBS,MAMS,FRCS

  Asian Institute Of Gastroenterology Private Limited

  PRINCIPAL INVESTIGATOR

Central Study Contacts

G V RAO, MBBS,MAMS,FRCS

CONTACT

+91-9182645727; gvraoaig@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterology

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: February 10, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share