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DeliriumNCT02603731

Delirium at the Intensive Care Unit - a Retrospective Cohort Study

An observational study of Delirium and Intensive Care Unit Syndrome, run by Zealand University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Delirium, Intensive Care Unit Syndrome
How many people
183 participants
Where
1 siteDenmark
Study dates
Aug 2015to Feb 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients admitted to the ICU at Køge Hospital in the study period

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Køge Sygehus

    Køge

Other trials in Denmark

About this 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.

Read the 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..

Medical subject headings
Delirium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Throughout study period, up to 6 months

Secondary outcomes (11)

  1. Days with delirium

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

    Measured: Throughout study period, up to 6 months

  2. Circadian light exposure

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

    Measured: Throughout study period, up to 6 months

  3. 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

    Measured: Throughout study period, up to 6 months

  4. Delirium in patients treated with steroids

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

    Measured: Throughout study period, up to 6 months

  5. Mortality

    Mortality within ICU stay

    Measured: Throughout study period, up to 6 months

  6. Demographic differences

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

    Measured: Throughout study period, up to 6 months

  7. Delirium and Simplified Acute Physiology Score (SAPS)

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

    Measured: Throughout study period, up to 6 months

  8. Delirium related to number of ventilator days

    Incidence of delirium associated to number of ventilator days

    Measured: Throughout study period, up to 6 months

  9. Delirium related to sedation

    Incidence of delirium associated to sedation infusion

    Measured: Throughout study period, up to 6 months

  10. Delirium related to admission type

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

    Measured: Throughout study period, up to 6 months

  11. Distribution of types of delirium

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

    Measured: Throughout study period, up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02603731
Sponsor's protocol ID
SE-DELIR1-15
Status last verified
Jun 2018
First submitted
4 Nov 2015
Last updated
2 Jul 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24088092

  • 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.

    PubMed 11445689

  • 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.

    PubMed 11730446

  • 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.

    PubMed 23647511

  • 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.

    PubMed 20473145

Questions about this trial

What is this clinical trial studying?

An observational study of Delirium and Intensive Care Unit Syndrome, run by Zealand University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delirium at any time point (time frame: Throughout study period, up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02603731, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.

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