Incidence and Predictors of Delirium After Cardiac Surgery (IPDACS)

This study has been completed.
Sponsor:
Information provided by:
Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT00784576
First received: November 3, 2008
Last updated: December 2, 2008
Last verified: November 2008
  Purpose

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
Delirium
Depression
Cognitive Impairment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence and Predictors of Delirium After Cardiac Surgery: A Prospective Observational Cohort Study

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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
Cardiac surgery patients
Individuals consecutively scheduled for cardiac surgery

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admitted to the Department of Cardiac Surgery in Lodz, Poland

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00784576

Locations
Poland
Department of Cardiac Surgery, 1st Chair of Cardiology and Cardiac Surgery, Medical University of Lodz
Lodz, Poland, 91-425
Sponsors and Collaborators
Medical Universtity of Lodz
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Universtity of Lodz, Poland, Medical Universtity of Lodz, Kosciuszki Street 4, 90-419 Lodz, Poland
ClinicalTrials.gov Identifier: NCT00784576     History of Changes
Other Study ID Numbers: 502-11-429
Study First Received: November 3, 2008
Last Updated: December 2, 2008
Health Authority: Poland: Ministry of Health
Poland: Ministry of Science and Higher Education
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Medical Universtity of Lodz:
Delirium
Cardiac Surgery
Depression
Cognitive Impairment
Diagnostic Criteria for Delirium
Memorial Delirium Assessment Scale
Delirium Index

Additional relevant MeSH terms:
Delirium
Depression
Depressive Disorder
Cognition Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on September 16, 2014