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Sponsored by: |
Medical Universtity of Lodz |
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Information provided by: | Medical Universtity of Lodz |
ClinicalTrials.gov Identifier: | NCT00784576 |
The objective of the present research is to evaluate the incidence and independent predictors of delirium observed among patients after cardiac surgery. Moreover, to asses the sensitivity and specificity of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria (DSM-IV) and International Statistical Classification of Diseases and Health Related Problems - Tenth Revision criteria (ICD-10), and the cut-off values of the Memorial Delirium Assessment Scale (MDAS) and Delirium Index (DI) in diagnosing postoperative delirium.
Condition |
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Delirium Depression Cognitive Impairment |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Incidence and Predictors of Delirium After Cardiac Surgery: A Prospective Observational Cohort Study |
Enrollment: | 563 |
Study Start Date: | November 2004 |
Study Completion Date: | October 2008 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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Cardiac surgery patients
Individuals consecutively scheduled for cardiac surgery
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Since 1954, the issue of delirium as a complication following cardiac surgery has been extensively investigated. Despite this, postoperative delirium is still a serious event that results in higher morbidity and mortality rates, and prolongs hospitalisation.
Moreover, there is a considerable discrepancy between studies on the incidence and risk factors of delirium among cardiac surgery patients.The first potential reason for this observation is retrospective design of some studies, secondly, the modest number of participants in numerous prospective studies which does not provide strong statistical power to select patients with delirium and detect risk factors of this complication. Unfortunately, reports with a more considerable number of patients often have methodological limitations. Additionally, in previous studies authors usually analyzed pre- and intraoperative variables ignoring potential postoperative risk factors of delirium. Finally, some variables which seem to have a crucial role in aetiology of delirium after cardiac surgery, particularly perioperative hypoxia, anaemia, and preoperative psychiatric disorders like depression and cognitive impairment, have not been properly investigated to date.
Therefore, we made an effort to design a prospective study on the incidence and predictors of delirium after different types of cardiac surgery, conducted by experienced investigators, and with the use of valid diagnostic tools.To our knowledge this is the first research pointing out the association between preoperative psychiatric comorbidity, anaemia and postoperative hypoxia, and delirium after cardiac surgery.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients admitted to the Department of Cardiac Surgery in Lodz, Poland
Inclusion Criteria:
Exclusion Criteria:
Poland | |
Department of Cardiac Surgery, 1st Chair of Cardiology and Cardiac Surgery, Medical University of Lodz | |
Lodz, Poland, 91-425 |
Principal Investigator: | Jakub Kazmierski, PhD | Department of Old-Age Psychiatry and Psychiatric Disorders, Medical University of Lodz, Poland |
Study Director: | Maciej Banach, PhD | Department of Cardiology, Medical University of Lodz, Poland |
Responsible Party: | Medical Universtity of Lodz, Kosciuszki Street 4, 90-419 Lodz, Poland ( Medical Universtity of Lodz, Poland ) |
Study ID Numbers: | 502-11-429 |
Study First Received: | November 3, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00784576 |
Health Authority: | Poland: Ministry of Health; Poland: Ministry of Scientific Research and Information Technology; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Delirium Cardiac Surgery Depression Cognitive Impairment |
Diagnostic Criteria for Delirium Memorial Delirium Assessment Scale Delirium Index |
Depression Confusion Depressive Disorder Cognition Disorders Behavioral Symptoms Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders |
Mental Disorders Mood Disorders Neurologic Manifestations Dementia Neurobehavioral Manifestations Delirium |
Nervous System Diseases |