NCT01902277

Brief Summary

ICU delirium negatively impacts on patient outcomes, as well as on resources and clinical workflow of the ICU. Effective healthcare resource planning requires reliable (i.e., multicentre) data that can inform on both of these. The purpose of this study was to determine the impact of ICU delirium in terms of both patients and beds. The study was carried out prospectively, over a one-week period, at adult ICUs comprising the Norfolk, Suffolk, and Cambridgeshire Critical Care Network (NSC CCN).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

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

June 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
Last Updated

July 18, 2013

Status Verified

July 1, 2013

Enrollment Period

1 month

First QC Date

July 15, 2013

Last Update Submit

July 17, 2013

Conditions

Keywords

DeliriumIntensive Care UnitCritical illness

Outcome Measures

Primary Outcomes (1)

  • Delirium prevalence

    Number of patients with at least one recorded delirium-positive result, over total number of patients recorded over study time frame. Delirium screening will be carried out using the CAM-ICU by local direct care clinicians in accordance with region-wide clinical delirium-screening guidelines.

    June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)

Secondary Outcomes (11)

  • Proportion of patient-days with delirium

    June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)

  • Median delirium duration

    June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)

  • Median days to transition to delirium

    June 25, 2012 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)

  • Patient age, by delirium status

    June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)

  • Patient gender, by delirium status

    June 25 (start of ICU day shift) to July 1, 2012 (end of ICU night shift)

  • +6 more secondary outcomes

Study Arms (1)

Adult critically ill patients

All adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK

Eligibility Criteria

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

Adult critically ill patients across eastern UK region

You may qualify if:

  • Adult patients treated within study time frame on Intensive Care Units across Norfolk, Suffolk, and Cambridgshire, UK

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 5EF, United Kingdom

Location

MeSH Terms

Conditions

DeliriumCritical Illness

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersDisease AttributesPathologic Processes

Study Officials

  • Alain Vuylsteke, MD

    Papworth Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 18, 2013

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 18, 2013

Record last verified: 2013-07

Locations