ABCDEF Bundle Compliance and ICU Outcomes in Latin America

NCT07783035 | Not Yet Recruiting DMC

• 1 other identifier: CEI2026-08/15/V1
• Study Type: observational
• Target: 580
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Icu Delirium; Post Intensive Care Syndrome; Critical Illness

Keywords

ABCDEF Bundle; Delirium; Intensive Care; Post Intensive Care Syndrome

Outcome Measures

Primary Outcomes (3)

• ICU Delirium Prevalence

  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

  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

  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).

Secondary Outcomes (13)

• Functional Mobility at ICU Discharge

  Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days)

• Achievement of Standing or Walking at ICU Discharge

  Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days).

• In-Hospital Mortality

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

• Post-ICU Cognitive Function at 3 Months

  3 months post-hospital discharge

• Post-ICU Cognitive Function at 6 Months

  6 months post-hospital discharge.

Study Arms (3)

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.

Other: ABCDEF Bundle Compliance Assessment

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.

Other: ABCDEF Bundle Compliance Assessment

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.

Other: ABCDEF Bundle Compliance Assessment

Interventions

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.

High ABCDEF Bundle Compliance; Low ABCDEF Bundle Compliance; Moderate ABCDEF Bundle Compliance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital H+ Queretaro: lead

MeSH Terms

Conditions

postintensive care syndrome; Critical Illness; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Job Heriberto Rodriguez Guillen

CONTACT

5549636548; job.rodriguez@hospitalesmac.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 24, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08