Clinical trial NCT00784576: Incidence and Predictors of Delirium After Cardiac Surgery
Official title: Incidence and Predictors of Delirium After Cardiac Surgery: A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Depression
Cognitive Impairment
Keywords: Delirium
Cardiac Surgery
Depression
Cognitive Impairment
Diagnostic Criteria for Delirium
Memorial Delirium Assessment Scale
Delirium Index
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2008-11-04
Enrollment: 563
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the Department of Cardiac Surgery in Lodz, Poland

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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;
timeFrame: one day before surgery; from the 2nd to the 6th day after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Department of Cardiac Surgery, 1st Chair of Cardiology and Cardiac Surgery, Medical University of Lodz
Study officials:
affiliation: Department of Old-Age Psychiatry and Psychiatric Disorders, Medical University of Lodz, Poland
name: Jakub Kazmierski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Medical University of Lodz, Poland
name: Maciej Banach, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Kazmierski J, Sobow T, Kloszewska I. [Delirium after cardiac surgery]. Kardiol Pol. 2007 May;65(5):583-7. No abstract available. Polish.
citation: 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.
citation: 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.
citation: 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.
citation: 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.