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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
History of Changes
  Purpose

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.


Condition Intervention
Delirium
 Other: systematic screening and treatment of delirium

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Incidence, Severity and Treatment of Delirium in Cardiac Surgery Patients: A Before-after Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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



Enrollment: 230
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: before
no systematic approach
Experimental: after
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774240

Locations
Denmark
Department of cardiothoracic surgery and intensive care 4142, Rigshospitalet, Blegdamsvej 6
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Vibeke L Jorgensen, MD, PhD Resident
  More Information

No publications provided

Responsible Party: Vibeke Lind Jørgensen, MD, PhD, resident, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01774240     History of Changes
Other Study ID Numbers: VJ1
Study First Received: January 1, 2013
Last Updated: January 20, 2013
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
Delirium
Cardiac surgery
DOS scale

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013