DeliriumIPDACSNCT00784576
Incidence and Predictors of Delirium After Cardiac Surgery
An observational study of Delirium and Depression, run by Medical University of Lodz at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Depression, Cognitive Impairment
- How many people
- 563 participants
- Where
- 1 sitePoland
- Study dates
- Nov 2004to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Department of Cardiac Surgery in Lodz, Poland
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Cardiac Surgery, 1st Chair of Cardiology and Cardiac Surgery, Medical University of Lodz
Lodz, Łódź Voivodeship, 91-425
About this study
Official title: Incidence and Predictors of Delirium After Cardiac Surgery: A Prospective Observational Cohort Study
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.
Read the 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.
- Conditions
- Delirium, Depression, Cognitive Impairment
- Keywords
- Delirium, Cardiac Surgery, Depression, Cognitive Impairment, Diagnostic Criteria for Delirium, Memorial Delirium Assessment Scale, Delirium Index
- Medical subject headings
- Delirium, Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery patients | Individuals consecutively scheduled for cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: one day before surgery; from the 2nd to the 6th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startNov 2004
- Primary completionApr 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Investigators
- Jakub Kazmierski, PhD, Principal investigator, Department of Old-Age Psychiatry and Psychiatric Disorders, Medical University of Lodz, PolandMaciej Banach, PhD, Study director, Department of Cardiology, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784576
- Sponsor's protocol ID
- 502-11-429
- Acronym
- IPDACS
- Status last verified
- Nov 2008
- First submitted
- 3 Nov 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17088170Kazmierski J, Sobow T, Kloszewska I. [Delirium after cardiac surgery]. Kardiol Pol. 2007 May;65(5):583-7. No abstract available. Polish.
PubMed 17577852Kazmierski 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.
PubMed 18212180Banach 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.
PubMed 18443554Kazmierski 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.
PubMed 21037128Kazmierski 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.
PubMed 20624517
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Predictors of Delirium After Cardiac Surgery: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT00784576
- Acronym / sponsor ID
- IPDACS / 502-11-429
- Conditions
- Delirium, Depression, Cognitive Impairment
- Keywords
- Delirium, Cardiac Surgery, Depression, Cognitive Impairment, Diagnostic Criteria for Delirium, Memorial Delirium Assessment Scale, Delirium Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | – | –Individuals consecutively scheduled for cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Department of Cardiac Surgery in Lodz, Poland
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2008.
- Results publication: PubMed 17088170Kazmierski 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.
- Results publication: PubMed 17577852Kazmierski J, Sobow T, Kloszewska I. [Delirium after cardiac surgery]. Kardiol Pol. 2007 May;65(5):583-7. No abstract available. Polish.
- Results publication: PubMed 18212180Kazmierski 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.
- Results publication: PubMed 18443554Banach 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.
- Derived from this study: PubMed 21037128Kazmierski 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.
- Derived from this study: PubMed 20624517Kazmierski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakub Kazmierski, PhD principal investigator
Department of Old-Age Psychiatry and Psychiatric Disorders, Medical University of Lodz, Poland
Maciej Banach, PhD study director
Department of Cardiology, Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Depression, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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; (time frame: one day before surgery; from the 2nd to the 6th day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00784576, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2008.