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Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study

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: NCT01774240
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Vibeke Lind Jørgensen, Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE January 1, 2013
First Posted Date  ICMJE January 23, 2013
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE April 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study
Official Title  ICMJE Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study
Brief Summary Delirium is a common yet under diagnosed condition in hospitalized patients, and the incidence have not previously been described in Danish cardiac surgery patients. The present study seeks to describe the incidence and duration of delirium in this group of patients, before and after the introduction of standardized screening tool and a guideline for treatment of delirium after cardiac surgery.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Delirium
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: before
    no systematic approach
  • Experimental: after
    systematic screening and treatment of delirium
    Intervention: Other: systematic screening and treatment of delirium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2013)
230
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients admitted for cardiac surgery at department of cardiothoracic surgery, Rigshospitalet, denmark

Exclusion Criteria:

  • patients under age 18,
  • patients that died within 24 hours after admission.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01774240
Other Study ID Numbers  ICMJE VJ1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vibeke Lind Jørgensen, Rigshospitalet, Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vibeke L Jorgensen, MD, PhD Resident
PRS Account Rigshospitalet, Denmark
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP