ABCDEF Bundle Compliance and ICU Outcomes in Latin America
20 de agosto de 2026 actualizado por: Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
ABCDEF Bundle Compliance and Outcomes in Latin American Intensive Care Units: An International Multicenter Prospective Observational Study
The goal of this observational study is to evaluate the degree of compliance with the ABCDEF bundle and its relationship with clinical outcomes in adult patients (aged 18 and older) admitted to intensive care units (ICUs) in Latin America for at least 48 hours.
The main questions it aims to answer are: What is the prevalence, cumulative incidence, and duration of delirium in adult ICU patients in Latin America? Is higher compliance with the ABCDEF bundle (low [<33%], moderate [33%-66%], high [>66%]) independently associated with a lower prevalence, cumulative incidence, and duration of delirium? Does higher ABCDEF bundle compliance improve functional mobility at hospital discharge and long-term cognitive, psychological, and quality-of-life outcomes at 3 and 6 months post-discharge? Researchers will compare three groups based on their level of ABCDEF bundle compliance (low [<33%], moderate [33%-66%], and high [>66%]) to see if higher bundle adherence improves delirium and long-term post-ICU functional outcomes.
Participants will:
Receive standard ICU care without experimental intervention. Undergo daily assessments for delirium (using CAM-ICU) and physical mobility (using ICU Mobility Scale) during their ICU stay.
Complete telephone follow-up evaluations at 3 months post-discharge to assess cognitive function (BCAT-ICU/MoCA) and psychological symptoms (HADS, DSPS).
Complete follow-up evaluations at 6 months post-discharge to assess cognitive function (full MoCA), psychological symptoms (HADS, DSPS), and health-related quality of life (EQ-5D-5L).
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
580
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Job Heriberto Rodriguez Guillen
- Número de teléfono: 52 5549636548
- Correo electrónico: job.rodriguez@hospitalesmac.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Adult critically ill patients admitted to six multipurpose intensive care units across four Latin American countries (Colombia, Mexico, Chile, and Argentina) with an expected ICU stay of at least 48 hours
Descripción
Inclusion Criteria:
- Age ≥18 years Admission to the ICU during the 3-month recruitment period
- Expected ICU length of stay ≥48 hours
- Written informed consent provided by the patient or legal representative (or eligibility for deferred consent according to local regulations)
Exclusion Criteria:
- History of moderate to severe dementia
- Severe chronic brain disease (e.g., previous disabling stroke, Parkinson's disease, advanced multiple sclerosis)
- Severe prior intellectual disability or prior functional cognitive dependence
- Palliative sedation scheduled from ICU admission
- Deep irreversible coma or diagnosed brain death
- Uncorrected bilateral deafness
- Non-Spanish speakers
- Refusal or explicit request by the family not to participate
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Low ABCDEF Bundle Compliance
Adult ICU patients who receive less than 33% of the ABCDEF bundle components (0 to 1 out of 6 components implemented) during their ICU stay.
|
Observational assessment of routine ICU clinical care practices implementing the ABCDEF bundle components (A: Sedation Assessment, B: Spontaneous Breathing Trials, C: Choice of Anesthesia/Sedation, D: Delirium Assessment and Management, E: Early Mobility, F: Family Engagement).
No experimental intervention is assigned by the study protocol.
|
|
Moderate ABCDEF Bundle Compliance
Adult ICU patients who receive between 33% and 66% of the ABCDEF bundle components (2 to 4 out of 6 components implemented) during their ICU stay.
|
Observational assessment of routine ICU clinical care practices implementing the ABCDEF bundle components (A: Sedation Assessment, B: Spontaneous Breathing Trials, C: Choice of Anesthesia/Sedation, D: Delirium Assessment and Management, E: Early Mobility, F: Family Engagement).
No experimental intervention is assigned by the study protocol.
|
|
High ABCDEF Bundle Compliance
Adult ICU patients who receive more than 66% of the ABCDEF bundle components (5 to 6 out of 6 components implemented) during their ICU stay.
|
Observational assessment of routine ICU clinical care practices implementing the ABCDEF bundle components (A: Sedation Assessment, B: Spontaneous Breathing Trials, C: Choice of Anesthesia/Sedation, D: Delirium Assessment and Management, E: Early Mobility, F: Family Engagement).
No experimental intervention is assigned by the study protocol.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ICU Delirium Prevalence
Periodo de tiempo: Daily during the ICU stay (up to hospital discharge or a maximum of 30 days)
|
Percentage of adult patients experiencing delirium at any point during their ICU stay, evaluated daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
|
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days)
|
|
ICU Delirium Cumulative Incidence
Periodo de tiempo: Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
|
Percentage of patients without delirium at ICU admission who subsequently develop delirium during their ICU stay, assessed daily using the CAM-ICU.
|
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
|
|
ICU Delirium Duration
Periodo de tiempo: Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
|
Total number of days with delirium during the ICU stay, calculated from daily CAM-ICU assessments.
|
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional Mobility at ICU Discharge
Periodo de tiempo: Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days)
|
Physical mobility evaluated using the ICU Mobility Scale (ICUMS), an 11-point scale ranging from 0 (nothing/lying in bed) to 10 (walking independently without a walking aid).
Higher scores represent better physical mobility and functional status.
|
Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days)
|
|
Achievement of Standing or Walking at ICU Discharge
Periodo de tiempo: Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days).
|
Percentage of patients reaching a functional mobility level of at least standing at bedside or walking (defined as an ICU Mobility Scale score ≥ 4) before ICU discharge.
|
Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days).
|
|
In-Hospital Mortality
Periodo de tiempo: From ICU admission up to hospital discharge (approximately 30 days).
|
Proportion of patients who died prior to hospital discharge.
|
From ICU admission up to hospital discharge (approximately 30 days).
|
|
Post-ICU Cognitive Function at 3 Months
Periodo de tiempo: 3 months post-hospital discharge
|
Global cognitive performance assessed using either the BCAT-ICU or the T-MoCA.
Scores range from 0 to 30 for BCAT-ICU (and 0 to 22 for T-MoCA), where higher scores indicate better cognitive performance.
|
3 months post-hospital discharge
|
|
Post-ICU Cognitive Function at 6 Months
Periodo de tiempo: 6 months post-hospital discharge.
|
Global cognitive performance assessed using the full Montreal Cognitive Assessment (MoCA).
Scores range from 0 to 30, where higher scores represent better cognitive function (a score of 26 or above is considered normal).
|
6 months post-hospital discharge.
|
|
Post-Traumatic Stress Symptoms at 3 Months
Periodo de tiempo: 3 months post-hospital discharge.
|
Psychological post-traumatic stress symptoms assessed using the 17-item Davidson Trauma Scale (DSPS).
Total scores range from 0 to 136, where higher scores indicate greater frequency and severity of post-traumatic stress symptoms (worse outcome).
|
3 months post-hospital discharge.
|
|
Post-Traumatic Stress Symptoms at 6 Months
Periodo de tiempo: 6 months post-hospital discharge.
|
Psychological post-traumatic stress symptoms assessed using the 17-item Davidson Trauma Scale (DSPS).
Total scores range from 0 to 136, where higher scores indicate greater frequency and severity of post-traumatic stress symptoms (worse outcome).
|
6 months post-hospital discharge.
|
|
Hospital Anxiety and Depression Scale - Anxiety Subscale at 3 Months
Periodo de tiempo: 3 months post-hospital discharge.
|
Psychological distress regarding anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A).
Scores range from 0 to 21, where higher scores indicate greater severity of anxiety symptoms (worse outcome; scores ≥ 8 suggest clinical anxiety).
|
3 months post-hospital discharge.
|
|
Hospital Anxiety and Depression Scale - Depression Subscale at 3 Months
Periodo de tiempo: 3 months post-hospital discharge.
|
Psychological distress regarding depression symptoms assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D).
Scores range from 0 to 21, where higher scores indicate greater severity of depressive symptoms (worse outcome; scores ≥ 8 suggest clinical depression).
|
3 months post-hospital discharge.
|
|
Hospital Anxiety and Depression Scale - Anxiety Subscale at 6 Months
Periodo de tiempo: 6 months post-hospital discharge.
|
Psychological distress regarding anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A).
Scores range from 0 to 21, where higher scores indicate greater severity of anxiety symptoms (worse outcome).
|
6 months post-hospital discharge.
|
|
Hospital Anxiety and Depression Scale - Depression Subscale at 6 Months
Periodo de tiempo: 6 months post-hospital discharge.
|
Psychological distress regarding depression symptoms assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D).
Scores range from 0 to 21, where higher scores indicate greater severity of depressive symptoms (worse outcome).
|
6 months post-hospital discharge.
|
|
EQ-5D-5L Index Score at 6 Months
Periodo de tiempo: 6 months post-hospital discharge.
|
Self-reported health status and quality of life evaluated across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
The index utility score ranges approximately from -0.6 to 1.0 (depending on national value sets), where higher scores represent better health-related quality of life (1.0 = perfect health).
|
6 months post-hospital discharge.
|
|
EQ-5D Visual Analog Scale (EQ-VAS) Score at 6 Months
Periodo de tiempo: 6 months post-hospital discharge.
|
Self-rated overall health status assessed using the EQ-5D Visual Analog Scale (EQ-VAS).
Scores range from 0 to 100 mm, where 0 represents the worst health you can imagine and 100 represents the best health you can imagine (higher scores represent better outcome).
|
6 months post-hospital discharge.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
24 de agosto de 2026
Finalización primaria (Estimado)
24 de noviembre de 2026
Finalización del estudio (Estimado)
30 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
17 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Procesos Patológicos
- Atributos de la enfermedad
- Confusión
- Manifestaciones neuroconductuales
- Trastornos neurocognitivos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Delirio
- Enfermedad crítica
- Síndrome de cuidados postintensivos
Otros números de identificación del estudio
- CEI2026-08/15/V1
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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