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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vibeke Lind Jørgensen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01774240
First received: January 1, 2013
Last updated: January 20, 2013
Last verified: January 2013

January 1, 2013
January 20, 2013
April 2012
October 2012   (final data collection date for primary outcome measure)
number of delirium free days [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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

Same as current
Complete list of historical versions of study NCT01774240 on ClinicalTrials.gov Archive Site
complication rates [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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

Same as current
Not Provided
Not Provided
 
Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study
Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.
  • No Intervention: before
    no systematic approach
  • Experimental: after
    systematic screening and treatment of delirium
    Intervention: Other: systematic screening and treatment of delirium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
December 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01774240
VJ1
No
Vibeke Lind Jørgensen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Vibeke L Jorgensen, MD, PhD Resident
Rigshospitalet, Denmark
January 2013

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