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Completed

NCT Number: NCT01774240

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

systematic screening and treatment of delirium

Other

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

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 23, 2013
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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