Delirium in Old AgeCICUDELNCT07776184
Multi-Component Delirium Prevention Bundle in Older Cardiac Intensive Care Unit Patients
A study testing Multicomponent Delirium Prevention Bundle in people with Delirium in Old Age and Delirium in the Intensive Care Unit, run by Tel Aviv Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Delirium in Old Age, Delirium in the Intensive Care Unit, Delirium Confusional State
- What is being tested?
- Multicomponent Delirium Prevention Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥70 years
- Expected CICU length of stay >24 hours
- Willing to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Cardiology, Sourasky University Medical Center
Tel Aviv
About this study
Official title: From Reactive Management to Proactive Prevention: Implementing a Multi-Component Bundle to Reduce Delirium in the Aging CICU Population
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.
Read more
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.
- Conditions
- Delirium in Old Age, Delirium in the Intensive Care Unit, Delirium Confusional State, Delirium, Cardiac Intensive Care Unit, Frailty in Older Adults
- Being tested
- Multicomponent Delirium Prevention Bundle, Control Group
- Keywords
- Delirium, cardiac intensive care unit, CICU, Acute coronary syndrome, Acute heart failure, Older adults, Frailty, Clinical Frailty Scale, Geriatric cardiology, Non-pharmacologic intervention, Delirium prevention, Early mobilization, CAM-ICU, MACE
- Medical subject headings
- Confusion, Delirium, Acute Coronary Syndrome, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent Delirium Prevention BundleOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Multicomponent Delirium-Prevention Bundle | Other | In the intervention arm, patients will receive the full delirium-prevention bundle. Receives: Other: Multicomponent Delirium Prevention Bundle |
| Usual CICU Care With Delirium Screening | Other | This group will receive the current standard of care provided in the CICU. Current delirium management in the CICU is limited, and there is no standardized protocol for delirium management. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Develop Delirium During Cardiac Intensive Care Unit Stay
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.
Measured: From admission to the cardiac intensive care unit through discharge from the cardiac intensive care unit
MACE
major adverse cardiac event: nonfatal stroke, nonfatal MI, cardiovascular death
Measured: From CICU admission through the geriatric cardiology clinic follow-up visit (up to 6 months).
Secondary outcomes (5)
Change in Katz Activities of Daily Living Score From Baseline to Post-Hospital Follow-up
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.
Measured: Baseline and 6 months after hospital discharge
Change in Mini-Mental State Examination Score From Baseline to Post-Hospital Follow-up
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.
Measured: Baseline and 6 months after hospital discharge
Change in Clinical Frailty Scale Score From Baseline to Post-Hospital Follow-up
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.
Measured: Baseline and 6 months after hospital discharge
Number of Participants With Adverse Events Related to Antipsychotic Medication Use
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.
Measured: From first administration of antipsychotic medication through discharge from the cardiac intensive care unit
Change in Barthel Index Score From Baseline to Post-Hospital Follow-up
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.
Measured: Baseline and 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start2 Jun 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Delirium in Old AgeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel-group randomized controlled design with two arms: an intervention arm and a usual-care control arm. Participants aged 70 years and older admitted to the cardiac intensive care unit (CICU) are randomized 1:1 to receive either a structured delirium prevention protocol plus standard care or standard care alone. In the intervention arm, participants receive a multicomponent non-pharmacologic bundle that includes daily pain assessment with age-appropriate analgesia, avoidance of benzodiazepines when feasible, daily CAM-ICU screening, sleep and sensory optimization (earplugs, eye masks, support for glasses and hearing aids, family presence when possible), and early mobilization including in-bed cycling. All geriatric, frailty, functional and cognitive assessments, as well as outcome evaluations, are performed by an independent geriatrician who is external to the CICU team.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel Aviv Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keren Lee Rozenfeld, Tel Aviv Medical Center
- Investigators
- Keren Lee Rozenfeld, MD, Principal investigator, Department of Cardiology, Tel Aviv Sourasky Medical CenterYishay Szekely, MD, Principal investigator, Department of Cardiology, Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776184
- Sponsor's protocol ID
- TLV-0064-26
- Acronym
- CICUDEL
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers because of privacy and confidentiality considerations and the absence of a formal data-sharing agreement.
Publications
Reznik ME, Slooter AJC. Delirium Management in the ICU. Curr Treat Options Neurol. 2019 Nov 14;21(11):59. doi: 10.1007/s11940-019-0599-5.
PubMed 31724092Naksuk N, Thongprayoon C, Park JY, Sharma S, Gaba P, Rosenbaum AN, Peeraphatdit T, Hu TY, Bell MR, Herasevich V, Brady PA, Kapa S, Asirvatham SJ. Editor's Choice-Clinical impact of delirium and antipsychotic therapy: 10-Year experience from a referral coronary care unit. Eur Heart J Acute Cardiovasc Care. 2017 Sep;6(6):560-568. doi: 10.1177/2048872615592232. Epub 2015 Jun 29.
PubMed 26124454Tan JF, Duan L, Han JC, Cui JJ. Clinical characteristics of delirium in older patients with first-ever acute myocardial infarction who underwent percutaneous coronary intervention : A retrospective study. Herz. 2024 Dec;49(6):456-463. doi: 10.1007/s00059-024-05250-5. Epub 2024 Jun 3.
PubMed 38829438Liu O, Sun PY, Ahmad SA, Kalra A, Feng A, Whitman GJR, Kim BS, Cho SM; HERALD Investigators. Characteristics and risk factors of delirium in patients on veno-arterial extracorporeal membrane oxygenation. Perfusion. 2025 Nov;40(8):1762-1771. doi: 10.1177/02676591251319684. Epub 2025 Mar 2.
PubMed 40025739Jackel M, Zotzmann V, Wengenmayer T, Duerschmied D, Biever PM, Spieler D, von Zur Muhlen C, Stachon P, Bode C, Staudacher DL. Incidence and predictors of delirium on the intensive care unit after acute myocardial infarction, insight from a retrospective registry. Catheter Cardiovasc Interv. 2021 Nov 15;98(6):1072-1081. doi: 10.1002/ccd.29275. Epub 2020 Sep 14.
PubMed 32926556Ko RE, Kim S, Lee J, Park S, Bae D, Choi KH, Park TK, Chung CR, Yang JH. Clinical phenotypes of delirium in patients admitted to the cardiac intensive care unit. PLoS One. 2022 Sep 2;17(9):e0273965. doi: 10.1371/journal.pone.0273965. eCollection 2022.
PubMed 36054128Falsini G, Grotti S, Porto I, Toccafondi G, Fraticelli A, Angioli P, Ducci K, Liistro F, Pieroni M, Taddei T, Romanelli S, Rossi R, Bolognese L. Long-term prognostic value of delirium in elderly patients with acute cardiac diseases admitted to two cardiac intensive care units: a prospective study (DELIRIUM CORDIS). Eur Heart J Acute Cardiovasc Care. 2018 Oct;7(7):661-670. doi: 10.1177/2048872617695235. Epub 2017 Mar 16.
PubMed 29064263Damluji AA, Forman DE, van Diepen S, Alexander KP, Page RL 2nd, Hummel SL, Menon V, Katz JN, Albert NM, Afilalo J, Cohen MG; American Heart Association Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing. Older Adults in the Cardiac Intensive Care Unit: Factoring Geriatric Syndromes in the Management, Prognosis, and Process of Care: A Scientific Statement From the American Heart Association. Circulation. 2020 Jan 14;141(2):e6-e32. doi: 10.1161/CIR.0000000000000741. Epub 2019 Dec 9.
PubMed 31813278Pauley E, Lishmanov A, Schumann S, Gala GJ, van Diepen S, Katz JN. Delirium is a robust predictor of morbidity and mortality among critically ill patients treated in the cardiac intensive care unit. Am Heart J. 2015 Jul;170(1):79-86, 86.e1. doi: 10.1016/j.ahj.2015.04.013. Epub 2015 Apr 17.
PubMed 26093867Mossello E, Baroncini C, Pecorella L, Giulietti C, Chiti M, Caldi F, Cavallini MC, Simoni D, Baldasseroni S, Fumagalli S, Valoti P, Stroppa S, Parenti K, Ungar A, Masotti G, Marchionni N, Bari MD. Predictors and prognosis of delirium among older subjects in cardiac intensive care unit: focus on potentially preventable forms. Eur Heart J Acute Cardiovasc Care. 2020 Oct;9(7):771-778. doi: 10.1177/2048872619882359. Epub 2019 Oct 16.
PubMed 31617374Salluh JI, Wang H, Schneider EB, Nagaraja N, Yenokyan G, Damluji A, Serafim RB, Stevens RD. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015 Jun 3;350:h2538. doi: 10.1136/bmj.h2538.
PubMed 26041151Faisal H, Farhat S, Grewal NK, Masud FN. ICU Delirium in Cardiac Patients. Methodist Debakey Cardiovasc J. 2023 Aug 1;19(4):74-84. doi: 10.14797/mdcvj.1246. eCollection 2023.
PubMed 37547895
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Reactive Management to Proactive Prevention: Implementing a Multi-Component Bundle to Reduce Delirium in the Aging CICU Population
- ClinicalTrials.gov ID
- NCT07776184
- Acronym / sponsor ID
- CICUDEL / TLV-0064-26
- Conditions
- Delirium in Old Age, Delirium in the Intensive Care Unit, Delirium Confusional State, Delirium, Cardiac Intensive Care Unit, Frailty in Older Adults
- Keywords
- Delirium, cardiac intensive care unit, CICU, Acute coronary syndrome, Acute heart failure, Older adults, Frailty, Clinical Frailty Scale
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel Aviv Medical CenterUniversity, hospital or other
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a parallel-group randomized controlled design with two arms: an intervention arm and a usual-care control arm. Participants aged 70 years and older admitted to the cardiac intensive care unit (CICU) are randomized 1:1 to receive either a structured delirium prevention protocol plus standard care or standard care alone. In the intervention arm, participants receive a multicomponent non-pharmacologic bundle that includes daily pain assessment with age-appropriate analgesia, avoidance of benzodiazepines when feasible, daily CAM-ICU screening, sleep and sensory optimization (earplugs, eye masks, support for glasses and hearing aids, family presence when possible), and early mobilization including in-bed cycling. All geriatric, frailty, functional and cognitive assessments, as well as outcome evaluations, are performed by an independent geriatrician who is external to the CICU team.
| Arm | Type | Receives |
|---|---|---|
| Geriatric Multicomponent Delirium-Prevention Bundle | Other | Other: Multicomponent Delirium Prevention BundleIn the intervention arm, patients will receive the full delirium-prevention bundle. |
| Usual CICU Care With Delirium Screening | Other | Other: Control GroupThis group will receive the current standard of care provided in the CICU. Current delirium management in the CICU is limited, and there is no standardized protocol for delirium management. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥70 years
- Expected CICU length of stay >24 hours
- Willing to participate in the study
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Multicomponent Delirium Prevention BundlePatients 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. | Other | Geriatric Multicomponent Delirium-Prevention Bundle |
| Control GroupPatients 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. | Other | Usual CICU Care With Delirium Screening |
Primary outcome
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.
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
5 secondary outcomes
Change in Katz Activities of Daily Living Score From Baseline to Post-Hospital Follow-up
Time frame: Baseline and 6 months after hospital discharge
Change in Mini-Mental State Examination Score From Baseline to Post-Hospital Follow-up
Time frame: Baseline and 6 months after hospital discharge
Change in Clinical Frailty Scale Score From Baseline to Post-Hospital Follow-up
Time frame: Baseline and 6 months after hospital discharge
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
Change in Barthel Index Score From Baseline to Post-Hospital Follow-up
Time frame: Baseline and 6 months after 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 21 Aug 2026.
- Background: PubMed 31724092Reznik ME, Slooter AJC. Delirium Management in the ICU. Curr Treat Options Neurol. 2019 Nov 14;21(11):59. doi: 10.1007/s11940-019-0599-5.
- Background: PubMed 26124454Naksuk N, Thongprayoon C, Park JY, Sharma S, Gaba P, Rosenbaum AN, Peeraphatdit T, Hu TY, Bell MR, Herasevich V, Brady PA, Kapa S, Asirvatham SJ. Editor's Choice-Clinical impact of delirium and antipsychotic therapy: 10-Year experience from a referral coronary care unit. Eur Heart J Acute Cardiovasc Care. 2017 Sep;6(6):560-568. doi: 10.1177/2048872615592232. Epub 2015 Jun 29.
- Background: PubMed 38829438Tan JF, Duan L, Han JC, Cui JJ. Clinical characteristics of delirium in older patients with first-ever acute myocardial infarction who underwent percutaneous coronary intervention : A retrospective study. Herz. 2024 Dec;49(6):456-463. doi: 10.1007/s00059-024-05250-5. Epub 2024 Jun 3.
- Background: PubMed 40025739Liu O, Sun PY, Ahmad SA, Kalra A, Feng A, Whitman GJR, Kim BS, Cho SM; HERALD Investigators. Characteristics and risk factors of delirium in patients on veno-arterial extracorporeal membrane oxygenation. Perfusion. 2025 Nov;40(8):1762-1771. doi: 10.1177/02676591251319684. Epub 2025 Mar 2.
- Background: PubMed 32926556Jackel M, Zotzmann V, Wengenmayer T, Duerschmied D, Biever PM, Spieler D, von Zur Muhlen C, Stachon P, Bode C, Staudacher DL. Incidence and predictors of delirium on the intensive care unit after acute myocardial infarction, insight from a retrospective registry. Catheter Cardiovasc Interv. 2021 Nov 15;98(6):1072-1081. doi: 10.1002/ccd.29275. Epub 2020 Sep 14.
- Background: PubMed 36054128Ko RE, Kim S, Lee J, Park S, Bae D, Choi KH, Park TK, Chung CR, Yang JH. Clinical phenotypes of delirium in patients admitted to the cardiac intensive care unit. PLoS One. 2022 Sep 2;17(9):e0273965. doi: 10.1371/journal.pone.0273965. eCollection 2022.
- Background: PubMed 29064263Falsini G, Grotti S, Porto I, Toccafondi G, Fraticelli A, Angioli P, Ducci K, Liistro F, Pieroni M, Taddei T, Romanelli S, Rossi R, Bolognese L. Long-term prognostic value of delirium in elderly patients with acute cardiac diseases admitted to two cardiac intensive care units: a prospective study (DELIRIUM CORDIS). Eur Heart J Acute Cardiovasc Care. 2018 Oct;7(7):661-670. doi: 10.1177/2048872617695235. Epub 2017 Mar 16.
- Background: PubMed 31813278Damluji AA, Forman DE, van Diepen S, Alexander KP, Page RL 2nd, Hummel SL, Menon V, Katz JN, Albert NM, Afilalo J, Cohen MG; American Heart Association Council on Clinical Cardiology and Council on Cardiovascular and Stroke Nursing. Older Adults in the Cardiac Intensive Care Unit: Factoring Geriatric Syndromes in the Management, Prognosis, and Process of Care: A Scientific Statement From the American Heart Association. Circulation. 2020 Jan 14;141(2):e6-e32. doi: 10.1161/CIR.0000000000000741. Epub 2019 Dec 9.
- Background: PubMed 26093867Pauley E, Lishmanov A, Schumann S, Gala GJ, van Diepen S, Katz JN. Delirium is a robust predictor of morbidity and mortality among critically ill patients treated in the cardiac intensive care unit. Am Heart J. 2015 Jul;170(1):79-86, 86.e1. doi: 10.1016/j.ahj.2015.04.013. Epub 2015 Apr 17.
- Background: PubMed 31617374Mossello E, Baroncini C, Pecorella L, Giulietti C, Chiti M, Caldi F, Cavallini MC, Simoni D, Baldasseroni S, Fumagalli S, Valoti P, Stroppa S, Parenti K, Ungar A, Masotti G, Marchionni N, Bari MD. Predictors and prognosis of delirium among older subjects in cardiac intensive care unit: focus on potentially preventable forms. Eur Heart J Acute Cardiovasc Care. 2020 Oct;9(7):771-778. doi: 10.1177/2048872619882359. Epub 2019 Oct 16.
- Background: PubMed 26041151Salluh JI, Wang H, Schneider EB, Nagaraja N, Yenokyan G, Damluji A, Serafim RB, Stevens RD. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015 Jun 3;350:h2538. doi: 10.1136/bmj.h2538.
- Background: PubMed 37547895Faisal H, Farhat S, Grewal NK, Masud FN. ICU Delirium in Cardiac Patients. Methodist Debakey Cardiovasc J. 2023 Aug 1;19(4):74-84. doi: 10.14797/mdcvj.1246. eCollection 2023.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers because of privacy and confidentiality considerations and the absence of a formal data-sharing agreement.
Related trials for Delirium in Old Age
RecruitingObservational study
Immunonutrition and Neuromonitoring for Postoperative Delirium in Gynecologic Oncology
Postoperative Delirium (POD), Gynecologic Cancers
RecruitingObservational study
Dexmedetomidine for Prevention of Delirium After Hip Fracture Surgery
Delirium - Postoperative, Delirium Prevention
RecruitingPhase 4
Lemborexant for Sleep and Delirium Prevention in Elderly ICU Patients
Sleep Disturbance, Delirium
RecruitingObservational study
Perioperative Biomarkers and Postoperative Delirium in Older Adults Undergoing Abdominal Cancer Surgery
Postoperative Delirium (POD), Abdominal Neoplasms
Not yet recruitingObservational study
Effects of PNB Timing on Postoperative Delirium for Hip Fracture
Delirium - Postoperative
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. This study is not recruiting at the moment.
Keren Lee Rozenfeld, MD principal investigator
Department of Cardiology, Tel Aviv Sourasky Medical Center
Yishay Szekely, MD principal investigator
Department of Cardiology, Tel Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent Delirium Prevention Bundle in people with Delirium in Old Age and Delirium in the Intensive Care Unit, run by Tel Aviv Medical Center at 1 site in Israel.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07776184, which also lists 12 linked publications.
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 21 Aug 2026.