FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS (EFI-ICU)
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS: A PROSPECTİVE OBSERVATİONAL STUDY
Enteral nutrition is the first-line nutritional support method in critically ill patients because it helps preserve gastrointestinal system integrity, reduce the risk of infection, and meet metabolic requirements. However, gastrointestinal motility is frequently impaired in critically ill patients due to physiological stress, hemodynamic instability, sedative and vasopressor medications, mechanical ventilation, and underlying diseases. This may result in enteral feeding intolerance (EFI), which complicates nutritional management.
This prospective observational study aims to determine the demographic, clinical, laboratory, and treatment-related factors associated with enteral feeding intolerance in adult intensive care unit patients and to evaluate the association between enteral feeding intolerance and morbidity and mortality.
Adult patients who are started on enteral nutrition in the Anesthesiology and Reanimation Intensive Care Unit will be prospectively followed. No additional intervention will be performed. Patients will be monitored according to routine intensive care and enteral nutrition protocols. Enteral feeding intolerance and potentially associated factors will be recorded prospectively.
The study is planned to include 102 patients.
Descripción general del estudio
Estado
Descripción detallada
Enteral nutrition is an important component of nutritional support in critically ill patients. However, enteral feeding intolerance is frequently observed in intensive care units and may result from impaired gastrointestinal motility associated with critical illness, hemodynamic instability, sedative and vasopressor use, mechanical ventilation, and underlying diseases.
In this study, demographic, clinical, laboratory, physiological, nutritional, and treatment-related variables that may affect the development of enteral feeding intolerance will be evaluated prospectively.
All adult patients admitted to the intensive care unit who are planned to receive enteral nutrition will be screened daily. Patients meeting the eligibility criteria will be enrolled after informed consent has been obtained from the patient or legally authorized representative.
Because this is an observational study, there will be no randomization and no investigator-assigned intervention. Patients will be classified according to their natural clinical course into an enteral feeding intolerance group and a non-enteral feeding intolerance group.
Demographic characteristics, admission diagnosis, APACHE II, SOFA, and Glasgow Coma Scale scores will be recorded. Daily clinical variables including bowel sounds, presence of stool, sedation, opioid use, vasopressor requirement, sepsis, and aspiration pneumonia will also be recorded.
Routine laboratory parameters including total protein, albumin, C-reactive protein, procalcitonin, lactate, hemoglobin, leukocyte count, and lymphocyte count will be obtained from the hospital electronic medical record twice weekly according to routine clinical practice.
The modified Nutrition Risk in Critically Ill (mNUTRIC) score and Prognostic Nutritional Index (PNI) will be calculated. Mechanical ventilation characteristics, enteral nutrition initiation time, formula type, daily energy and protein targets, delivered amounts, and interruptions of enteral nutrition will be recorded.
Enteral feeding intolerance will be assessed according to predefined criteria and international recommendations. The following findings will be considered enteral feeding intolerance: vomiting, a single gastric residual volume greater than 250 mL, a 24-hour gastric residual volume greater than 500 mL, abdominal distension, and suspected aspiration.
Gastric residual volume will be measured by intensive care nurses using a 50-mL syringe according to the standard intensive care unit protocol.
Intra-abdominal pressure will be measured twice weekly as part of routine intensive care practice using the Foley bladder pressure measurement technique.
All study data will be obtained from routine clinical records, laboratory results, enteral nutrition monitoring charts, ventilator records, and the hospital electronic medical record. No additional invasive procedure, imaging study, surgical procedure, or other intervention will be performed for research purposes.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Eda Cirit Bardakci, Medical Doctor
- Número de teléfono: +90 541 308 9295
- Correo electrónico: edacrt@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
The study population will consist of adult patients aged 18 years or older who are admitted to the Anesthesiology and Reanimation Intensive Care Unit of Ankara Atatürk Sanatoryum Training and Research Hospital and who are started on enteral nutrition.
Patients will be prospectively screened and consecutively enrolled if they meet all inclusion criteria and none of the exclusion criteria.
Descripción
Inclusion Criteria:
- Age ≥18 years
- Admission to the Anesthesia Intensive Care Unit
- Enteral nutrition planned or initiated during intensive care unit admission
- Expected to require enteral nutrition during intensive care unit follow-up
- Availability of sufficient clinical and nutritional data for study evaluation
- Patient or legally authorized representative provides informed consent when required by the ethics protocol
Exclusion Criteria:
- Age <18 years
- Patients receiving only parenteral nutrition
- Patients in whom enteral nutrition is contraindicated throughout the observation period
- Patients with insufficient data for evaluation of enteral feeding tolerance
- Patients transferred to another intensive care unit before adequate study assessment
- Patients who decline participation or whose legally authorized representative declines participation when consent is required
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Occurrence of Enteral Feeding Intolerance
Periodo de tiempo: 7 days
|
Enteral feeding intolerance will be defined by the presence of at least one predefined clinical criterion: vomiting, a single gastric residual volume greater than 250 mL, 24-hour cumulative gastric residual volume greater than 500 mL, abdominal distension, or clinical suspicion of aspiration related to enteral feeding.
|
7 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Achievement of Energy Target
Periodo de tiempo: 3 days
|
The proportion of prescribed or calculated daily energy target actually delivered through enteral nutrition.
Achievement of ≥70-80% of the calculated daily energy target will be considered adequate.
|
3 days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- 2024-BCEK/483
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .