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NCT02356523 Clinical Trial

Incidence and Prognostic Value of Delirium in Patients With Acute Coronary Syndromes

Delirium Clinical Trial

Official title:
Long-term Prognostic Value of Delirium in Elderly Patients With Acute Coronary Syndrome Admitted to Two Cardiac Intensive Care Units: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02356523
Other study ID # Arezzo014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2014
Est. completion date October 2015

Study information
Verified date March 2023
Source Ospedale San Donato
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The Purpose of this study is to evaluate the incidence of delirium in patients with acute coronary syndromes admitted to a Intensive Care Unit Patients.

Description:

The present study is a prospective, two-centre registry aimed at assessing the incidence, prevalence and prognostic significance of delirium in elderly patients with acute coronary syndromes

Recruitment information / eligibility
Status Completed
Enrollment 700
Est. completion date October 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Admission in Cardiac Intensive Care Unit - Age = 65 years Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Confusion Assessment Method
Administration of Confusion Assessment Method at patent over 65 years at admission and every day until discharge

Locations
Country Name City State
Italy Cardiovascular Department, Ospedale S.Donato Arezzo AR

Sponsors (1)
Lead Sponsor Collaborator
Ospedale San Donato

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Hsieh SJ, Ely EW, Gong MN. Can intensive care unit delirium be prevented and reduced? Lessons learned and future directions. Ann Am Thorac Soc. 2013 Dec;10(6):648-56. doi: 10.1513/AnnalsATS.201307-232FR. — View Citation

Inouye SK. Delirium in hospitalized older patients: recognition and risk factors. J Geriatr Psychiatry Neurol. 1998 Fall;11(3):118-25; discussion 157-8. doi: 10.1177/089198879801100302. — View Citation

McPherson JA, Wagner CE, Boehm LM, Hall JD, Johnson DC, Miller LR, Burns KM, Thompson JL, Shintani AK, Ely EW, Pandharipande PP. Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med. 2013 Feb;41(2):405-13. doi: 10.1097/CCM.0b013e31826ab49b. Erratum In: Crit Care Med. 2013 Apr;41(4):e41. Pandhvaripande, Pratik P [corrected to Pandharipande, Pratik P]. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary diagnosis of delirium by confusion assessment method incidence of delirium in elderly patients with coronary acute syndromes within 24 hours of admission
Secondary adverse events incidence any adverse event occurred to patients during hospital stay not due to the illness 6 months
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