Delirium at the Intensive Care Unit - a Retrospective Cohort Study

Delirium Clinical Trial

Official title:

Delirium at the Intensive Care Unit - a Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603731
• Other study ID #: SE-DELIR1-15
• Status: Completed
• Start date: August 2015
• Est. completion date: February 2016

Study information

• Verified date: June 2018
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Intensive Care Unit Syndrome

Locations

Country	Name	City	State
Denmark	Køge Sygehus	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

Svenningsen H, Tønnesen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium at any time point	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.	Throughout study period, up to 6 months
Secondary	Days with delirium	Days with positive CAM-ICU or CAM-ICU negative delirium treated with anti-psychotics in relation to length of stay (LOS)	Throughout study period, up to 6 months
Secondary	Circadian light exposure	Difference in incidences of delirium between patients admitted to rooms with circadian rhythm lighting and standard rooms	Throughout study period, up to 6 months
Secondary	Delirium in patients treated with hypnotics	Difference in incidence of delirium in patients treated with hypnotics before admission to hospital (ATC N05C) compared to those who are not	Throughout study period, up to 6 months
Secondary	Delirium in patients treated with steroids	Differences in incidences of delirium in patients that are treated with systemic steroids vs. no treatment	Throughout study period, up to 6 months
Secondary	Mortality	Mortality within ICU stay	Throughout study period, up to 6 months
Secondary	Demographic differences	Incidence of delirium associated to demographic variables (age, gender)	Throughout study period, up to 6 months
Secondary	Delirium and Simplified Acute Physiology Score (SAPS)	Incidence of delirium associated to Simplified Acute Physiology Score (SAPS) II	Throughout study period, up to 6 months
Secondary	Delirium related to number of ventilator days	Incidence of delirium associated to number of ventilator days	Throughout study period, up to 6 months
Secondary	Delirium related to sedation	Incidence of delirium associated to sedation infusion	Throughout study period, up to 6 months
Secondary	Delirium related to admission type	Incidence of delirium associated to admission type (medical/elective surgical/acute surgical)	Throughout study period, up to 6 months
Secondary	Distribution of types of delirium	Incidence and distribution of delirium subtypes (hypoactive/hyperactive/mixed)	Throughout study period, up to 6 months