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Incidence and Predictors of Delirium After Cardiac Surgery (IPDACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00784576
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : December 3, 2008
Information provided by:
Medical University of Lodz

Brief Summary:
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 or disease
Delirium Depression Cognitive Impairment

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 563 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence and Predictors of Delirium After Cardiac Surgery: A Prospective Observational Cohort Study
Study Start Date : November 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Cardiac surgery patients
Individuals consecutively scheduled for cardiac surgery

Primary Outcome Measures :
  1. MMSE and MINI - to assess cognitive performance and psychiatric comorbidity; DSM-IV and ICD-10 criteria; MDAS and DI - to estimate the incidence and severity of postoperative delirium; [ Time Frame: one day before surgery; from the 2nd to the 6th day after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the Department of Cardiac Surgery in Lodz, Poland

Inclusion Criteria:

  • Patients 18 years old and older
  • Patients who signed an informed consent
  • Patients scheduled for cardiac surgery with extracorporeal circulation (coronary-artery bypass grafting (CABG), cardiac valve replacement (CVR), combined CABG + CVR, excision of cardiac myxoma)

Exclusion Criteria:

  • Patients who refuse to participate before or after operation
  • Patients who undergo urgent surgery
  • Patients in poor general condition
  • Patients with preoperative dementia, delirium or illiterate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00784576

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Department of Cardiac Surgery, 1st Chair of Cardiology and Cardiac Surgery, Medical University of Lodz
Lodz, Poland, 91-425
Sponsors and Collaborators
Medical University of Lodz
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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
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medical Universtity of Lodz, Poland, Medical Universtity of Lodz, Kosciuszki Street 4, 90-419 Lodz, Poland Identifier: NCT00784576    
Other Study ID Numbers: 502-11-429
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: December 3, 2008
Last Verified: November 2008
Keywords provided by Medical University of Lodz:
Cardiac Surgery
Cognitive Impairment
Diagnostic Criteria for Delirium
Memorial Delirium Assessment Scale
Delirium Index
Additional relevant MeSH terms:
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Cognitive Dysfunction
Behavioral Symptoms
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases