Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study
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|ClinicalTrials.gov Identifier: NCT01774240|
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : January 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Delirium||Other: systematic screening and treatment of delirium||Not Applicable|
Delirium is a common yet under diagnosed condition in cardiac surgery patients, and may cause prolonged cognitive impairment and increased risk of complications. Patients are at risk of e.g. pulling catheters and lines and may fall attempting to get out of bed. The aging patient population present with many risk factors for developing delirium, but diagnostic tools have been few. Almost 50% present with hypoactive delirium, which is often not diagnosed, nor treated correctly. To optimize effect, treatment should be initiated early, maintained until clinical improvement is observed, and then tapered gradually. Recently, Delirium Observation Screening scale (DOS scale) was developed and validated in elective cardiac surgery patients in the Netherlands, with interesting results. This encouraged us to evaluate the effects of systematic delirium screening and treatment in cardiac surgery patients. To our knowledge, no prior studies have evaluated use of DOS scale in this context.
OBJECTIVES To evaluate the incidence and severity of delirium, and the effects of standardized treatment in a population of Danish cardiac surgery patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||December 2012|
No Intervention: before
no systematic approach
systematic screening and treatment of delirium
Other: systematic screening and treatment of delirium
systematic screening for delirium with DOS scale and CAM ICU. In case of delirium, treatment according to guidelines.
- number of delirium free days [ Time Frame: 14 days ]
number of delirium free days are calculated as percentage of length of stay (LOS) in days.
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
- complication rates [ Time Frame: 14 days ]
complications: respiratory, re-operation, infection, acute kidney injury (AKI), cerebral, cardiac, bleeding.
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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): NCT01774240
|Department of cardiothoracic surgery and intensive care 4142, Rigshospitalet, Blegdamsvej 6|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Vibeke L Jorgensen, MD, PhD||Resident|