NCT01774240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 1, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

January 1, 2013

Last Update Submit

November 16, 2023

Conditions

Delirium

Keywords

DeliriumCardiac surgeryDOS scale

Outcome Measures

Primary Outcomes (1)

  • 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

    14 days

Secondary Outcomes (1)

  • complication rates

    14 days

Study Arms (2)

before

NO INTERVENTION

no systematic approach

after

EXPERIMENTAL

systematic screening and treatment of delirium

Other: systematic screening and treatment of delirium

Interventions

systematic screening and treatment of deliriumOTHER

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

after

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients admitted for cardiac surgery at department of cardiothoracic surgery, Rigshospitalet, denmark

You may not qualify if:

  • patients under age 18,
  • patients that died within 24 hours after admission.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Vibeke L Jorgensen, MD, PhD

    Resident

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, resident

Study Record Dates

First Submitted

January 1, 2013

First Posted

January 23, 2013

Study Start

April 1, 2012

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

DK(1)