Clinical Research Directory
Browse clinical research sites, groups, and studies.
Multi-Component Delirium Prevention Bundle in Older Cardiac Intensive Care Unit Patients
Sponsor: Tel Aviv Medical Center
Summary
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.
Official title: From Reactive Management to Proactive Prevention: Implementing a Multi-Component Bundle to Reduce Delirium in the Aging CICU Population
Key Details
Gender
All
Age Range
70 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-06-02
Completion Date
2027-12-31
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
Multicomponent Delirium Prevention Bundle
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
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.
Locations (1)
Department of Cardiology, Sourasky University Medical Center
Tel Aviv, Israel