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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAsian Institute of Gastroenterology, India

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

Allergy to the study medications or excipients

Need for enteral feeding

Estimated survival of <96 hours

Pregnant and breastfeeding females.

Trial design

Treatments tested in this trial

  • Esomeprazole

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

This trial has no locations