- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07399054
Eficacia y seguridad de esomeprazol 40 mg IV en pacientes postquirúrgicos ingresados en la UCI
Eficacia y Seguridad de Esomeprazol 40 mg IV en Pacientes Postquirúrgicos Ingresados en la UCI (EPIC-ICU)
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: G V RAO, MBBS,MAMS,FRCS
- Número de teléfono: +91-9182645727
- Correo electrónico: gvraoaig@gmail.com
Ubicaciones de estudio
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Telangana
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Hyderabad, Telangana, India, 500032
- Reclutamiento
- AIG Hospitals
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Contacto:
- AIG Hospitals
- Número de teléfono: +91 4042444222
- Correo electrónico: info@aighospitals.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
50
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of time intragastric pH ≥4 during the 72 hours post dosing
Periodo de tiempo: From enrollment to the end of treatment at 72 hours
|
Proportion of time intragastric pH ≥4 during the 72 hours post dosing |
From enrollment to the end of treatment at 72 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
• To assess the safety and tolerability of IV Esomeprazole in this patient population, including the incidence of stress ulcers and reflux episodes.
Periodo de tiempo: From enrollment to the end of treatment at 72 hours
|
• 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.) |
From enrollment to the end of treatment at 72 hours
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: G V RAO, MBBS,MAMS,FRCS, Asian Institute Of Gastroenterology Private Limited
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades intestinales
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Enfermedades Duodenales
- Úlcera péptica
- Úlcera duodenal
- 2-piridinilmetilsulfinilbenzimidazoles
- Sulfóxidos
- Compuestos de azufre
- Químicos orgánicos
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Benzimidazoles
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Omeprazol
- Esomeprazol
Otros números de identificación del estudio
- EPIC-ICU
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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