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NCT07783035
ABCDEF Bundle Compliance and ICU Outcomes in Latin America
Conditions: Icu Delirium, Post Intensive Care Syndrome, Critical Illness
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 580
Sponsor: Hospital H+ Queretaro
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 \[\66%\]) 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 \[\66%\]) 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
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
Source: ClinicalTrials.gov (NCT07783035). StuddyBuddy aggregates publicly available trial information.