ABCDEF Bundle Compliance and ICU Outcomes in Latin America
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital H+ Queretaro
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ABCDEF Bundle Compliance Assessment
Other interventionObservational 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.
Treatment groups
580 Participants
are divided into 3 treatment groupsGroup A: Low ABCDEF Bundle Compliance1 intervention
Group B: Moderate ABCDEF Bundle Compliance1 intervention
Group C: High ABCDEF Bundle Compliance1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days)2
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.
Time frame
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).3
ICU Delirium Duration
Total number of days with delirium during the ICU stay, calculated from daily CAM-ICU assessments.
Time frame
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).Secondary outcomes
1
Functional Mobility at ICU Discharge
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.
Time frame
Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days)2
Achievement of Standing or Walking at ICU Discharge
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.
Time frame
Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days).3
In-Hospital Mortality
Proportion of patients who died prior to hospital discharge.
Time frame
From ICU admission up to hospital discharge (approximately 30 days).4
Post-ICU Cognitive Function at 3 Months
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.
Time frame
3 months post-hospital dischargeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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