Clinical trial NCT02603731: Delirium at the Intensive Care Unit - a Retrospective Cohort Study
Official title: Delirium at the Intensive Care Unit - a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Intensive Care Unit Syndrome
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the ICU at Køge Hospital in the study period

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..

Eligibility criteria: 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)

Primary outcomes:
measure: Delirium at any time point
timeFrame: Throughout study period, up to 6 months
Secondary outcomes:
measure: Days with delirium
timeFrame: Throughout study period, up to 6 months
measure: Circadian light exposure
timeFrame: Throughout study period, up to 6 months
measure: Delirium in patients treated with hypnotics
timeFrame: Throughout study period, up to 6 months
measure: Delirium in patients treated with steroids
timeFrame: Throughout study period, up to 6 months
measure: Mortality
timeFrame: Throughout study period, up to 6 months
measure: Demographic differences
timeFrame: Throughout study period, up to 6 months
measure: Delirium and Simplified Acute Physiology Score (SAPS)
timeFrame: Throughout study period, up to 6 months
measure: Delirium related to number of ventilator days
timeFrame: Throughout study period, up to 6 months
measure: Delirium related to sedation
timeFrame: Throughout study period, up to 6 months
measure: Delirium related to admission type
timeFrame: Throughout study period, up to 6 months
measure: Distribution of types of delirium
timeFrame: Throughout study period, up to 6 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Køge Sygehus
Study officials:
affiliation: Køge Hospital
name: Ole Mathiesen, MD, PhD
role: STUDY_CHAIR
References:
citation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
citation: Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
citation: Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
citation: Svenningsen H, Tonnesen EK, Videbech P, Frydenberg M, Christensen D, Egerod I. Intensive care delirium - effect on memories and health-related quality of life - a follow-up study. J Clin Nurs. 2014 Mar;23(5-6):634-44. doi: 10.1111/jocn.12250. Epub 2013 May 6.
citation: Girard TD, Jackson JC, Pandharipande PP, Pun BT, Thompson JL, Shintani AK, Gordon SM, Canonico AE, Dittus RS, Bernard GR, Ely EW. Delirium as a predictor of long-term cognitive impairment in survivors of critical illness. Crit Care Med. 2010 Jul;38(7):1513-20. doi: 10.1097/CCM.0b013e3181e47be1.