Incidence and Predictors of Delirium After Cardiac Surgery

Depression Clinical Trial

— IPDACS  

Official title:

Incidence and Predictors of Delirium After Cardiac Surgery: A Prospective Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784576
• Other study ID #: 502-11-429
• Status: Completed
• Phase: N/A
• First received: November 3, 2008
• Last updated: December 2, 2008
• Start date: November 2004
• Est. completion date: October 2008

Study information

• Verified date: November 2008
• Source: Medical Universtity of Lodz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of HealthPoland: Ministry of Science and Higher EducationPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: October 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Delirium
• Depression

Locations

Country	Name	City	State
Poland	Department of Cardiac Surgery, 1st Chair of Cardiology and Cardiac Surgery, Medical University of Lodz	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Medical Universtity of Lodz

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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 — View 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 su — View 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. — View Citation

Kazmierski J, Sobów T, Kloszewska I. [Delirium after cardiac surgery]. Kardiol Pol. 2007 May;65(5):583-7. Review. Polish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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;		one day before surgery; from the 2nd to the 6th day after surgery	Yes