NCT02603731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

November 4, 2015

Last Update Submit

June 29, 2018

Conditions

DeliriumIntensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (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.

    Throughout study period, up to 6 months

Secondary Outcomes (11)

  • Days with delirium

    Throughout study period, up to 6 months

  • Circadian light exposure

    Throughout study period, up to 6 months

  • Delirium in patients treated with hypnotics

    Throughout study period, up to 6 months

  • Delirium in patients treated with steroids

    Throughout study period, up to 6 months

  • Mortality

    Throughout study period, up to 6 months

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Køge Sygehus

Køge, Denmark

Location

Related Publications (5)

  • 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.

    PMID: 24088092BACKGROUND

  • 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.

    PMID: 11445689BACKGROUND

  • 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.

    PMID: 11730446BACKGROUND

  • 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.

    PMID: 23647511BACKGROUND

  • 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.

    PMID: 20473145BACKGROUND

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Ole Mathiesen, MD, PhD

    Køge Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Doctor

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 13, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 2, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)