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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774240
First Posted: January 23, 2013
Last Update Posted: January 23, 2013
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.
Information provided by (Responsible Party):
Vibeke Lind Jørgensen, Rigshospitalet, Denmark
  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: None (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:


Further study details as provided by Vibeke Lind Jørgensen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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



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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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

Responsible Party: Vibeke Lind Jørgensen, MD, PhD, resident, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01774240     History of Changes
Other Study ID Numbers: VJ1
First Submitted: January 1, 2013
First Posted: January 23, 2013
Last Update Posted: January 23, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders