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NCT Number: NCT07783035

ABCDEF Bundle Compliance and ICU Outcomes in Latin America

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).

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Key information

Conditions

ICU Delirium Confusion Critical Illness Delirium Disease Attributes Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Post Intensive Care Syndrome Signs and Symptoms postintensive care syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABCDEF Bundle Compliance Assessment

Other

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.

Primary outcomes

  1. ICU Delirium Prevalence

    Time frame: 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).

  2. ICU Delirium Cumulative Incidence

    Time frame: 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.

  3. ICU Delirium Duration

    Time frame: 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.

Secondary outcomes

  1. Functional Mobility at ICU Discharge

    Time frame: 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.

  2. Achievement of Standing or Walking at ICU Discharge

    Time frame: 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.

  3. In-Hospital Mortality

    Time frame: From ICU admission up to hospital discharge (approximately 30 days).

    Proportion of patients who died prior to hospital discharge.

  4. Post-ICU Cognitive Function at 3 Months

    Time frame: 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.

  5. Post-ICU Cognitive Function at 6 Months

    Time frame: 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. Post-Traumatic Stress Symptoms at 3 Months

    Time frame: 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).

  7. Post-Traumatic Stress Symptoms at 6 Months

    Time frame: 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).

  8. Hospital Anxiety and Depression Scale - Anxiety Subscale at 3 Months

    Time frame: 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).

  9. Hospital Anxiety and Depression Scale - Depression Subscale at 3 Months

    Time frame: 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).

  10. Hospital Anxiety and Depression Scale - Anxiety Subscale at 6 Months

    Time frame: 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).

  11. Hospital Anxiety and Depression Scale - Depression Subscale at 6 Months

    Time frame: 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).

  12. EQ-5D-5L Index Score at 6 Months

    Time frame: 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).

  13. EQ-5D Visual Analog Scale (EQ-VAS) Score at 6 Months

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Job Heriberto Rodriguez Guillen

CONTACT

[email protected]

5549636548 ext. 52

Sponsors and collaborators

Lead sponsor

Hospital H+ Queretaro

Other

Registry information

Official study title

ABCDEF Bundle Compliance and Outcomes in Latin American Intensive Care Units: An International Multicenter Prospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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