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

Официальное название

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

Обзор

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

Подробное описание

Esomeprazole, a PPI, has demonstrated robust efficacy in the management of gastroesophageal reflux disease (GERD).4 An intravenous (IV) formulation has been developed to facilitate administration in patients for whom oral therapy is not feasible. A study assessed the safety profile after 1 and 4 weeks, as well as the efficacy after 4 weeks of treatment with esomeprazole 40 mg once daily. Their findings indicated that esomeprazole, administered either as an IV bolus, IV infusion, or orally for 1 week followed by 3 weeks of oral dosing, was well tolerated and effectively promoted mucosal healing.5 Similarly, another studyreported significant improvements in symptom control, with mean reductions in heartburn (91.6%), acid regurgitation (96%), belching (96.8%), epigastric pain (88.4%), and dysphagia (84.7%). Based on both investigator and patient global assessments, 89.2% of cases were rated as having an excellent to good therapeutic response.6

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

In view of this evidence, the present study was designed to evaluate the efficacy of IV esomeprazole for intragastric pH control in post-surgical patients admitted to the ICU, as well as to assess its safety and tolerability in this population

Вмешательства

• Препарат 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.

Первичные конечные точки

• Proportion of time intragastric pH ≥4 during the 72 hours post dosing [Срок оценки: From enrollment to the end of treatment at 72 hours]

Вторичные конечные точки (1)

• • To assess the safety and tolerability of IV Esomeprazole in this patient population, including the incidence of stress ulcers and reflux episodes. [Срок оценки: From enrollment to the end of treatment at 72 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07399054 · EPIC-ICU

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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