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Active, not recruiting

NCT Number: NCT07776184

Multi-Component Delirium Prevention Bundle in Older Cardiac Intensive Care Unit Patients

The goal of this randomized controlled clinical trial is to learn whether a structured delirium prevention protocol can reduce the occurrence of delirium in older adults admitted to the cardiac intensive care unit (CICU). The study will include participants aged 70 years and older who are hospitalized in the CICU with acute cardiac conditions. The main questions it aims to answer are:

Does a structured non-pharmacologic delirium prevention protocol lower the incidence of delirium compared with usual care in older CICU patients? Does this protocol improve short- and long-term clinical outcomes, such as major adverse cardiac events (MACE), functional decline, and cognitive impairment? Researchers will compare participants randomly assigned to receive the delirium prevention protocol (intervention group) with participants receiving usual CICU care (control group) to see if the protocol leads to fewer episodes of delirium and better clinical and functional outcomes.

Participants will:

Be randomly assigned to the intervention group or the control group. Undergo daily delirium screening using the CAM-ICU tool. Be evaluated by an independent geriatrician who is not the principal investigator, and who will perform all clinical and geriatric assessments external to the treating CICU team.

In the intervention group, receive a structured prevention protocol that includes: daily pain assessment using the VAS scale and age-appropriate analgesia as needed, avoiding benzodiazepines when possible, use of earplugs and eye masks at night, early mobilization including bedside cycling exercises, and support for vision and hearing (use of glasses and hearing aids) and family presence overnight.

In the control group, receive usual CICU care, including delirium screening with CAM-ICU according to unit practice.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Delirium in Old Age Acute Coronary Syndrome Acute Coronary Syndromes (ACS) Cardiac Intensive Care Unit Cardiovascular Diseases Confusion Delirium Delirium Confusional State Delirium in the Intensive Care Unit Frailty Frailty in Older Adults Heart Diseases Mental Disorders Myocardial Ischemia Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Sourasky University Medical Center

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥70 years
  • Expected CICU length of stay >24 hours
  • Willing to participate in the study

Exclusion criteria

  • Age <70 years
  • Delirium diagnosed prior to admission to the Cardiac Intensive Care Unit (CICU).
  • Diagnosis of delirium tremens
  • Diagnosis of advanced dementia
  • Terminal condition, with an anticipated life expectancy of less than 48 hours
  • Receiving invasive mechanical ventilation
  • Inability to provide informed consent

Treatment and study plan

Multicomponent Delirium Prevention Bundle

Other

Patients will undergo daily assessment with CAM-ICU by a geriatrician participating in the study, who is not part of the CICU treating team or the principal investigator group.

Patients will undergo daily pain assessment using the Visual Analog Scale (VAS). Analgesia will be administered as needed according to the CICU established delirium protocol.

Hypnotic medications will be administered only to patients with an established home regimen of such medications; in patients without a pre-existing home regimen, benzodiazepine administration will be avoided.

Use of earplugs to minimize background noise; Eye masks during nighttime hours; Encouraging family presence overnight; Ensuring the use of sensory aids (glasses and hearing aids). Implementation of an early mobilization. Reorientation will be provided by the nursing staff every eight hours. Follow-up at the cardio-geriatric clinic within 6 months, including a comprehensive cardiac evaluation and provide recommendations for management.

Control Group

Other

Patients will undergo daily assessment with CAM-ICU by a geriatrician participating in the study, who is not part of the CICU treating team or the principal investigator group.

During the study, there will be no restriction on any components considered standard of care.

Follow-up at the cardio-geriatric clinic within 6 months, including a comprehensive cardiac evaluation and provide recommendations for management.

Primary outcomes

  1. Number of Participants Who Develop Delirium During Cardiac Intensive Care Unit Stay

    Time frame: From admission to the cardiac intensive care unit through discharge from the cardiac intensive care unit

    Delirium will be assessed once daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), from admission to the cardiac intensive care unit through discharge from the unit. Delirium will be defined as at least one positive CAM-ICU assessment during the cardiac intensive care unit stay.

  2. MACE

    Time frame: From CICU admission through the geriatric cardiology clinic follow-up visit (up to 6 months).

    major adverse cardiac event: nonfatal stroke, nonfatal MI, cardiovascular death

Secondary outcomes

  1. Change in Katz Activities of Daily Living Score From Baseline to Post-Hospital Follow-up

    Time frame: Baseline and 6 months after hospital discharge

    Functional status will be assessed using the Katz Index of Independence in Activities of Daily Living. The total score ranges from 0 to 6, with higher scores indicating greater independence in activities of daily living. Functional decline will be defined as a decrease of at least 1 point from the baseline score to the post-hospital follow-up assessment.

  2. Change in Mini-Mental State Examination Score From Baseline to Post-Hospital Follow-up

    Time frame: Baseline and 6 months after hospital discharge

    Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Cognitive performance will be compared between the baseline assessment and the post-hospital follow-up assessment.

  3. Change in Clinical Frailty Scale Score From Baseline to Post-Hospital Follow-up

    Time frame: Baseline and 6 months after hospital discharge

    Frailty will be assessed using the Clinical Frailty Scale. The Clinical Frailty Scale ranges from 1 to 9, with higher scores indicating greater frailty. Change in Clinical Frailty Scale score will be assessed by comparing the baseline assessment with the post-hospital follow-up assessment.

  4. Number of Participants With Adverse Events Related to Antipsychotic Medication Use

    Time frame: From first administration of antipsychotic medication through discharge from the cardiac intensive care unit

    Adverse events occurring after administration of antipsychotic medication will be assessed through clinical evaluation, electrocardiographic monitoring, laboratory results, and review of medical records. Events considered related to antipsychotic medication by the study investigator will be recorded. A participant will be counted once if one or more adverse events related to antipsychotic medication occur during the assessment period.

  5. Change in Barthel Index Score From Baseline to Post-Hospital Follow-up

    Time frame: Baseline and 6 months after hospital discharge

    Functional status will be assessed using the Barthel Index. The total score ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living. Functional decline will be defined as a decrease of at least 10 points from the baseline score to the post-hospital follow-up assessment.

Sponsors and collaborators

Lead sponsor

Tel Aviv Medical Center

Other

Registry information

Official study title

From Reactive Management to Proactive Prevention: Implementing a Multi-Component Bundle to Reduce Delirium in the Aging CICU Population

Acronym: CICUDEL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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