Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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 population
50
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Esomeprazole
DrugEsomeprazole 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Single Prospective Observational Cohort - Post-surgical ICU Patients1 intervention
Trial outcomes
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
Time frame
From enrollment to the end of treatment at 72 hoursSecondary outcomes
1
• 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 hoursSponsors and contacts
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Source ClinicalTrials.gov