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.|
|ClinicalTrials.gov Identifier: NCT00784576|
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : December 3, 2008
|Condition or disease|
|Delirium Depression Cognitive Impairment|
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.
|Study Type :||Observational|
|Actual Enrollment :||563 participants|
|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|
Cardiac surgery patients
Individuals consecutively scheduled for cardiac surgery
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00784576
|Department of Cardiac Surgery, 1st Chair of Cardiology and Cardiac Surgery, Medical University of Lodz|
|Lodz, Poland, 91-425|
|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|