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Incidence and Predictors of Delirium After Cardiac Surgery

NCT ID: NCT00784576

Last Updated: 2008-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

563 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Study Completion Date

2008-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Delirium Depression Cognitive Impairment

Keywords

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Delirium Cardiac Surgery Depression Cognitive Impairment Diagnostic Criteria for Delirium Memorial Delirium Assessment Scale Delirium Index

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac surgery patients

Individuals consecutively scheduled for cardiac surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Lodz

OTHER

Sponsor Role lead

Responsible Party

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Medical Universtity of Lodz, Kosciuszki Street 4, 90-419 Lodz, Poland

Principal Investigators

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Jakub Kazmierski, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Old-Age Psychiatry and Psychiatric Disorders, Medical University of Lodz, Poland

Maciej Banach, PhD

Role: STUDY_DIRECTOR

Department of Cardiology, Medical University of Lodz, Poland

Locations

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Department of Cardiac Surgery, 1st Chair of Cardiology and Cardiac Surgery, Medical University of Lodz

Lodz, Łódź Voivodeship, Poland

Site Status

Countries

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Poland

References

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Kazmierski J, Kowman M, Banach M, Pawelczyk T, Okonski P, Iwaszkiewicz A, Zaslonka J, Sobow T, Kloszewska I. Preoperative predictors of delirium after cardiac surgery: a preliminary study. Gen Hosp Psychiatry. 2006 Nov-Dec;28(6):536-8. doi: 10.1016/j.genhosppsych.2006.08.007.

Reference Type RESULT
PMID: 17088170 (View on PubMed)

Kazmierski J, Sobow T, Kloszewska I. [Delirium after cardiac surgery]. Kardiol Pol. 2007 May;65(5):583-7. No abstract available. Polish.

Reference Type RESULT
PMID: 17577852 (View on PubMed)

Kazmierski J, Kowman M, Banach M, Fendler W, Okonski P, Banys A, Jaszewski R, Sobow T, Kloszewska I. Clinical utility and use of DSM-IV and ICD-10 Criteria and The Memorial Delirium Assessment Scale in establishing a diagnosis of delirium after cardiac surgery. Psychosomatics. 2008 Jan-Feb;49(1):73-6. doi: 10.1176/appi.psy.49.1.73.

Reference Type RESULT
PMID: 18212180 (View on PubMed)

Banach M, Kazmierski J, Kowman M, Okonski PK, Sobow T, Kloszewska I, Mikhailidis DP, Goch A, Banys A, Rysz J, Goch JH, Jaszewski R. Atrial fibrillation as a nonpsychiatric predictor of delirium after cardiac surgery: a pilot study. Med Sci Monit. 2008 May;14(5):CR286-291.

Reference Type RESULT
PMID: 18443554 (View on PubMed)

Kazmierski J, Kowman M, Banach M, Fendler W, Okonski P, Banys A, Jaszewski R, Rysz J, Sobow T, Kloszewska I. The use of DSM-IV and ICD-10 criteria and diagnostic scales for delirium among cardiac surgery patients: results from the IPDACS study. J Neuropsychiatry Clin Neurosci. 2010 Fall;22(4):426-32. doi: 10.1176/jnp.2010.22.4.426.

Reference Type DERIVED
PMID: 21037128 (View on PubMed)

Kazmierski J, Kowman M, Banach M, Fendler W, Okonski P, Banys A, Jaszewski R, Rysz J, Mikhailidis DP, Sobow T, Kloszewska I; IPDACS Study. Incidence and predictors of delirium after cardiac surgery: Results from The IPDACS Study. J Psychosom Res. 2010 Aug;69(2):179-85. doi: 10.1016/j.jpsychores.2010.02.009. Epub 2010 Mar 30.

Reference Type DERIVED
PMID: 20624517 (View on PubMed)

Other Identifiers

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502-11-429

Identifier Type: -

Identifier Source: org_study_id