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Completed

NCT Number: NCT02603731

Delirium at the Intensive Care Unit - a Retrospective Cohort Study

This project seeks to describe the incidence of delirium in the Intensive Care Unit (ICU) and to identify risk and preventive factors associated with development of delirium.

Especially, the investigators want to investigate if an imitated natural light/dark cycle influences frequency of delirium.

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Key information

Conditions

Delirium Confusion Intensive Care Unit Syndrome Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Køge Sygehus

Køge, Denmark

About this study

A common problem for patients in the ICU is episodes of delirium. Recent trials have described incidences ranging from 60-87% of patients in a number of different countries. Delirium is a condition with fluctuating conscience, disorganized thinking and disturbance of the sleep/wake cycle. Many patients with delirium experience hallucinations and agitation which can be very unpleasant for both patients and their families.

Some risk factors for the development of delirium well known, e.g. dementia, hypertension, illness severity (SAPS II score), delirium on the previous day, mechanical ventilation, emergency surgery and metabolic acidosis. The effect of sedative drug administration is not clear, as studies has been inconclusive.

Even though studies regarding the impact of sleep deprivation on development of delirium have been inconclusive, there is no doubt that delirious patients have a disturbed sleep-wake cycle, sleep architecture and circadian rhythm.

At the intensive care unit at the Department of Anesthesiology at Køge Hospital, three out of nine rooms have a simulated circadian light installed. The idea is that this light rhythm may help to keep a natural circadian rhythm, minimizing the risk of delirium.

With this descriptive and retrospective cohort study, the investigators therefore want to describe the incidence and possible risk- and preventive factors of delirium for the participants (ICU patients at Køge Hospital), and with a special focus on the possible effect of imitated circadian light..

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients >18 years of age admitted to the ICU at Køge Hospital in the study period

Exclusion criteria

  • Richmond Agitation Sedation Score (RASS): -4 or -5 during the whole study period
  • No CAM-ICU scores during the ICU stay
  • Unable to communicate in Danish (aphasic, deaf, non-Danish speaking, severe brain damage)
  • Severe dementia documented in electronic patient charts (OPUS)
  • Patients not receiving active treatment (moribund patients)

Treatment and study plan

Primary outcomes

  1. Delirium at any time point

    Time frame: Throughout study period, up to 6 months

    Incidence of patients with delirium during ICU-stay defined as at least one positive Confusion Assessment Method for the ICU (CAM-ICU) score or CAM-ICU negative delirium treated with anti-psychotics.

Secondary outcomes

  1. Days with delirium

    Time frame: Throughout study period, up to 6 months

    Days with positive CAM-ICU or CAM-ICU negative delirium treated with anti-psychotics in relation to length of stay (LOS)

  2. Circadian light exposure

    Time frame: Throughout study period, up to 6 months

    Difference in incidences of delirium between patients admitted to rooms with circadian rhythm lighting and standard rooms

  3. Delirium in patients treated with hypnotics

    Time frame: Throughout study period, up to 6 months

    Difference in incidence of delirium in patients treated with hypnotics before admission to hospital (ATC N05C) compared to those who are not

  4. Delirium in patients treated with steroids

    Time frame: Throughout study period, up to 6 months

    Differences in incidences of delirium in patients that are treated with systemic steroids vs. no treatment

  5. Mortality

    Time frame: Throughout study period, up to 6 months

    Mortality within ICU stay

  6. Demographic differences

    Time frame: Throughout study period, up to 6 months

    Incidence of delirium associated to demographic variables (age, gender)

  7. Delirium and Simplified Acute Physiology Score (SAPS)

    Time frame: Throughout study period, up to 6 months

    Incidence of delirium associated to Simplified Acute Physiology Score (SAPS) II

  8. Delirium related to number of ventilator days

    Time frame: Throughout study period, up to 6 months

    Incidence of delirium associated to number of ventilator days

  9. Delirium related to sedation

    Time frame: Throughout study period, up to 6 months

    Incidence of delirium associated to sedation infusion

  10. Delirium related to admission type

    Time frame: Throughout study period, up to 6 months

    Incidence of delirium associated to admission type (medical/elective surgical/acute surgical)

  11. Distribution of types of delirium

    Time frame: Throughout study period, up to 6 months

    Incidence and distribution of delirium subtypes (hypoactive/hyperactive/mixed)

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2015
Registry last updated
Jul 2, 2018

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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