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CICUDEL
From Reactive Management to Proactive Prevention: Implementing a Multi-Component Bundle to Reduce Delirium in the Aging CICU Population
Sponsor study identifier
interventional
200
1 country
1
Study Start
June 2, 2026
Actual (reported)Primary Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2, 2026
Actual (reported)August 5, 2026
Actual (reported)August 20, 2026
Actual (reported)September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
From CICU admission through the geriatric cardiology clinic follow-up visit (up to 6 months).
In the intervention arm, patients will receive the full delirium-prevention bundle.
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.
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.
Department of Cardiology, Sourasky University Medical Center
Tel Aviv, Israel
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.
Naksuk 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.
Keren Lee Rozenfeld, MD
Department of Cardiology, Tel Aviv Sourasky Medical Center
Yishay Szekely, MD
Department of Cardiology, Tel Aviv Sourasky Medical Center
First Submitted
August 5, 2026
Change in Katz Activities of Daily Living Score From Baseline to Post-Hospital Follow-up
Baseline and 6 months after hospital discharge
Change in Mini-Mental State Examination Score From Baseline to Post-Hospital Follow-up
Baseline and 6 months after hospital discharge
Change in Clinical Frailty Scale Score From Baseline to Post-Hospital Follow-up
Baseline and 6 months after hospital discharge
Number of Participants With Adverse Events Related to Antipsychotic Medication Use
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
Baseline and 6 months after hospital discharge
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Tan 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.
Liu 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.
Jackel 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.
Ko 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.
Falsini 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.
Damluji 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.
Pauley 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.
Mossello 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.
Salluh 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.
Faisal 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.
First Posted
August 20, 2026
Study Start
June 2, 2026
Actual (reported)Primary Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-08
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.
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Source: ClinicalTrials.gov.
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