Incidence and Predictors of Delirium After Cardiac Surgery

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.

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Key information

Conditions

Delirium Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Cognitive Impairment Confusion Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lodz, Łódź Voivodeship, 91-425, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Medical University of Lodz

Other

Registry information

Official study title

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

Acronym: IPDACS

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2008
First posted: Nov 4, 2008
Registry last updated: Dec 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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