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

NCT ID: NCT01774240

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-12-31

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.

Conditions

Delirium

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

before

no systematic approach

Group Type: NO_INTERVENTION

No interventions assigned to this group

after

systematic screening and treatment of delirium

Group Type: EXPERIMENTAL

systematic screening and treatment of delirium

Intervention Type: OTHER

systematic screening for delirium with DOS scale and CAM ICU. In case of delirium, treatment according to guidelines.

Interventions

systematic screening and treatment of delirium

systematic screening for delirium with DOS scale and CAM ICU. In case of delirium, treatment according to guidelines.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Vibeke Lind Jørgensen

MD, PhD, resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vibeke L Jorgensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Resident

Locations

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

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

VJ1

Identifier Type: -

Identifier Source: org_study_id