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Delirium at the Intensive Care Unit - a Retrospective Cohort Study

Delirium at the Intensive Care Unit - a Retrospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02603731
Enrollment
183
Registered
2015-11-13
Start date
2015-08-31
Completion date
2016-02-29
Last updated
2018-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Intensive Care Unit Syndrome

Brief summary

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.

Detailed description

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..

Interventions

None listed

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Delirium at any time pointThroughout study period, up to 6 monthsIncidence 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

MeasureTime frameDescription
Days with deliriumThroughout study period, up to 6 monthsDays with positive CAM-ICU or CAM-ICU negative delirium treated with anti-psychotics in relation to length of stay (LOS)
Circadian light exposureThroughout study period, up to 6 monthsDifference in incidences of delirium between patients admitted to rooms with circadian rhythm lighting and standard rooms
Delirium in patients treated with hypnoticsThroughout study period, up to 6 monthsDifference in incidence of delirium in patients treated with hypnotics before admission to hospital (ATC N05C) compared to those who are not
Delirium in patients treated with steroidsThroughout study period, up to 6 monthsDifferences in incidences of delirium in patients that are treated with systemic steroids vs. no treatment
MortalityThroughout study period, up to 6 monthsMortality within ICU stay
Demographic differencesThroughout study period, up to 6 monthsIncidence of delirium associated to demographic variables (age, gender)
Delirium and Simplified Acute Physiology Score (SAPS)Throughout study period, up to 6 monthsIncidence of delirium associated to Simplified Acute Physiology Score (SAPS) II
Delirium related to number of ventilator daysThroughout study period, up to 6 monthsIncidence of delirium associated to number of ventilator days
Delirium related to sedationThroughout study period, up to 6 monthsIncidence of delirium associated to sedation infusion
Delirium related to admission typeThroughout study period, up to 6 monthsIncidence of delirium associated to admission type (medical/elective surgical/acute surgical)
Distribution of types of deliriumThroughout study period, up to 6 monthsIncidence and distribution of delirium subtypes (hypoactive/hyperactive/mixed)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026