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

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
systematic screening and treatment of delirium
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Delirium, Cardiac surgery, DOS scale

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of cardiothoracic surgery and intensive care 4142, Rigshospitalet, Blegdamsvej 6

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

before

after

Arm Description

no systematic approach

systematic screening and treatment of delirium

Outcomes

Primary Outcome Measures

number of delirium free 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

Secondary Outcome Measures

complication rates
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

Full Information

First Posted
January 1, 2013
Last Updated
January 20, 2013
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01774240
Brief Title
Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study
Official Title
Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Cardiac surgery, DOS scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
before
Arm Type
No Intervention
Arm Description
no systematic approach
Arm Title
after
Arm Type
Experimental
Arm Description
systematic screening and treatment of delirium
Intervention Type
Other
Intervention Name(s)
systematic screening and treatment of delirium
Intervention Description
systematic screening for delirium with DOS scale and CAM ICU. In case of delirium, treatment according to guidelines.
Primary Outcome Measure Information:
Title
number of delirium free days
Description
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
Time Frame
14 days
Secondary Outcome Measure Information:
Title
complication rates
Description
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
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vibeke L Jorgensen, MD, PhD
Organizational Affiliation
Resident
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of cardiothoracic surgery and intensive care 4142, Rigshospitalet, Blegdamsvej 6
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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

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