Icu DeliriumNCT07783035
ABCDEF Bundle Compliance and ICU Outcomes in Latin America
An observational study of Icu Delirium and Post Intensive Care Syndrome, run by Hospital H+ Queretaro.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Icu Delirium, Post Intensive Care Syndrome, Critical Illness
- What is being tested?
- ABCDEF Bundle Compliance Assessment
- How many people
- 580 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Being tested
- ABCDEF Bundle Compliance Assessment
- Keywords
- ABCDEF Bundle, Delirium, Intensive Care, Post Intensive Care Syndrome
- Medical subject headings
- postintensive care syndrome, Critical Illness, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABCDEF Bundle Compliance AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: ABCDEF Bundle Compliance Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
Secondary outcomes (13)
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.
Measured: Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days)
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.
Measured: Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days).
In-Hospital Mortality
Proportion of patients who died prior to hospital discharge.
Measured: From ICU admission up to hospital discharge (approximately 30 days).
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.
Measured: 3 months post-hospital discharge
Post-ICU Cognitive Function at 6 Months
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).
Measured: 6 months post-hospital discharge.
Post-Traumatic Stress Symptoms at 3 Months
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).
Measured: 3 months post-hospital discharge.
Post-Traumatic Stress Symptoms at 6 Months
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).
Measured: 6 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Anxiety Subscale at 3 Months
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).
Measured: 3 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Depression Subscale at 3 Months
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).
Measured: 3 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Anxiety Subscale at 6 Months
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).
Measured: 6 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Depression Subscale at 6 Months
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).
Measured: 6 months post-hospital discharge.
EQ-5D-5L Index Score at 6 Months
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).
Measured: 6 months post-hospital discharge.
EQ-5D Visual Analog Scale (EQ-VAS) Score at 6 Months
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).
Measured: 6 months post-hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start24 Aug 2026 (estimated)
- Primary completion24 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Icu DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783035
- Sponsor's protocol ID
- CEI2026-08/15/V1
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABCDEF Bundle Compliance and Outcomes in Latin American Intensive Care Units: An International Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07783035
- Acronym / sponsor ID
- CEI2026-08/15/V1
- Conditions
- Icu Delirium, Post Intensive Care Syndrome, Critical Illness
- Keywords
- ABCDEF Bundle, Delirium, Intensive Care, Post Intensive Care Syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 24 Aug 2026 (estimated)
- Primary completion
- 24 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low ABCDEF Bundle Compliance | – | Other: ABCDEF Bundle Compliance AssessmentAdult ICU patients who receive less than 33% of the ABCDEF bundle components (0 to 1 out of 6 components implemented) during their ICU stay. |
| Moderate ABCDEF Bundle Compliance | – | Other: ABCDEF Bundle Compliance AssessmentAdult 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. |
| High ABCDEF Bundle Compliance | – | Other: ABCDEF Bundle Compliance AssessmentAdult ICU patients who receive more than 66% of the ABCDEF bundle components (5 to 6 out of 6 components implemented) during their ICU stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABCDEF Bundle Compliance AssessmentObservational 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. | Other | High ABCDEF Bundle Compliance, Low ABCDEF Bundle Compliance, Moderate ABCDEF Bundle Compliance |
Primary outcome
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).
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.
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.
13 secondary outcomes
Functional Mobility at ICU Discharge
Time frame: Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days)
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).
In-Hospital Mortality
Time frame: From ICU admission up to hospital discharge (approximately 30 days).
Post-ICU Cognitive Function at 3 Months
Time frame: 3 months post-hospital discharge
Post-ICU Cognitive Function at 6 Months
Time frame: 6 months post-hospital discharge.
Post-Traumatic Stress Symptoms at 3 Months
Time frame: 3 months post-hospital discharge.
Post-Traumatic Stress Symptoms at 6 Months
Time frame: 6 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Anxiety Subscale at 3 Months
Time frame: 3 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Depression Subscale at 3 Months
Time frame: 3 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Anxiety Subscale at 6 Months
Time frame: 6 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Depression Subscale at 6 Months
Time frame: 6 months post-hospital discharge.
EQ-5D-5L Index Score at 6 Months
Time frame: 6 months post-hospital discharge.
EQ-5D Visual Analog Scale (EQ-VAS) Score at 6 Months
Time frame: 6 months post-hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Icu Delirium and Post Intensive Care Syndrome, run by Hospital H+ Queretaro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Job Heriberto Rodriguez Guillen (5549636548 ext. 52, job.rodriguez@hospitalesmac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Delirium Prevalence (time frame: Daily during the ICU stay (up to hospital discharge or a maximum of 30 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.