A new care routine aims to shield aging hearts and minds in the ICU

NCT ID NCT07776184

Ongoing Prevention Sponsor: Tel Aviv Medical Center Source: ClinicalTrials.gov ↗

Running, but no longer taking on new participants.

First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a structured prevention bundle can reduce delirium in adults aged 70 and older admitted to a cardiac intensive care unit (CICU). Participants are randomly assigned to either usual care or the bundle, which includes daily pain checks, avoiding sedatives when possible, earplugs and eye masks at night, early mobility exercises, and support for vision and hearing. The goal is to see if this approach lowers delirium rates and improves short- and long-term outcomes like heart events, functional decline, and cognitive issues.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: A structured non-pharmacologic delirium prevention bundle including daily pain assessment, avoiding sedatives when possible, earplugs and eye masks at night, early mobilization, sensory aids, and family presence overnight.
What this could lead to: If effective, this bundle could become a standard preventive approach to reduce delirium and improve recovery in older cardiac ICU patients.
What could go wrong: The trial is relatively small and the intervention is complex, so results may not be conclusive or widely applicable. Some components may be hard to implement consistently.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome Confusion Frailty delirium prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE CORONARY SYNDROMES (ACS) CARDIAC INTENSIVE CARE UNIT DELIRIUM DELIRIUM CONFUSIONAL STATE DELIRIUM IN OLD AGE DELIRIUM IN THE INTENSIVE CARE UNIT FRAILTY IN OLDER ADULTS