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

November 16, 2023 updated by: Vibeke Lind Jørgensen, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of cardiothoracic surgery and intensive care 4142, Rigshospitalet, Blegdamsvej 6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Vibeke L Jorgensen, MD, PhD, Resident

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 1, 2013

First Submitted That Met QC Criteria

January 20, 2013

First Posted (Estimated)

January 23, 2013

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VJ1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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