Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

ABCDEF Bundle Compliance and ICU Outcomes in Latin America

20 augustus 2026 bijgewerkt door: Jose J Zaragoza, MD MSc, Hospital H+ Queretaro

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.

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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

580

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: ABCDEF Bundle Compliance Assessment
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.
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.
Ander: ABCDEF Bundle Compliance Assessment
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
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.
Ander: ABCDEF Bundle Compliance Assessment
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
ICU Delirium Prevalence
Tijdsspanne: 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).
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days)
ICU Delirium Cumulative Incidence
Tijdsspanne: 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.
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).
ICU Delirium Duration
Tijdsspanne: 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.
Daily during the ICU stay (up to hospital discharge or a maximum of 30 days).

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functional Mobility at ICU Discharge
Tijdsspanne: 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.
Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days)
Achievement of Standing or Walking at ICU Discharge
Tijdsspanne: 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.
Assessed every 48 hours during the ICU stay until ICU discharge (up to 30 days).
In-Hospital Mortality
Tijdsspanne: From ICU admission up to hospital discharge (approximately 30 days).
Proportion of patients who died prior to hospital discharge.
From ICU admission up to hospital discharge (approximately 30 days).
Post-ICU Cognitive Function at 3 Months
Tijdsspanne: 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.
3 months post-hospital discharge
Post-ICU Cognitive Function at 6 Months
Tijdsspanne: 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 months post-hospital discharge.
Post-Traumatic Stress Symptoms at 3 Months
Tijdsspanne: 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).
3 months post-hospital discharge.
Post-Traumatic Stress Symptoms at 6 Months
Tijdsspanne: 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).
6 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Anxiety Subscale at 3 Months
Tijdsspanne: 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).
3 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Depression Subscale at 3 Months
Tijdsspanne: 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).
3 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Anxiety Subscale at 6 Months
Tijdsspanne: 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).
6 months post-hospital discharge.
Hospital Anxiety and Depression Scale - Depression Subscale at 6 Months
Tijdsspanne: 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).
6 months post-hospital discharge.
EQ-5D-5L Index Score at 6 Months
Tijdsspanne: 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).
6 months post-hospital discharge.
EQ-5D Visual Analog Scale (EQ-VAS) Score at 6 Months
Tijdsspanne: 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).
6 months post-hospital discharge.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hospital H+ Queretaro

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

24 augustus 2026

Primaire voltooiing (Geschat)

24 november 2026

Studie voltooiing (Geschat)

30 november 2026

Studieregistratiedata

Eerst ingediend

17 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 augustus 2026

Eerst geplaatst (Werkelijk)

24 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

20 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CEI2026-08/15/V1

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren