NCT00919698

Brief Summary

The overall purpose of this trial is to assess the relationship between a daily awakening from sedation and the prevalence of delirium, and in doing so better characterize delirium in the ICU.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Typical duration 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

First Submitted

Initial submission to the registry

June 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

3.3 years

First QC Date

June 10, 2009

Last Update Submit

December 2, 2014

Conditions

Delirium

Keywords

Hypnotics and SedativesRespiration, ArtificialVentilators, MechanicalCritical careIntensive care

Outcome Measures

Primary Outcomes (1)

  • Delirium

    Daily

Secondary Outcomes (6)

  • ICU admitting diagnosis

    At enrollment

  • Medications

    Daily

  • Ventilator free days (or first 28)

    At 28 days post-intubation

  • ICU complications

    Daily

  • Days to discharge

    At discharge

  • +1 more secondary outcomes

Other Outcomes (2)

  • survival

    1 year

  • institution free days

    1 year

Study Arms (1)

Sedated mechanically ventilated patients

Eligibility Criteria

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

Adult patients (\> 18 years old) admitted to the intensive care unit who require mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic medication.

You may qualify if:

  • \> 18 years old
  • intubated and mechanically ventilated
  • receiving sedative and/or analgesic medication
  • candidate for daily awakening from sedative and/or analgesic medication

You may not qualify if:

  • primary neurologic disease (stroke, seizure, elevated ICP)
  • post cardiac arrest
  • do not speak English (assessment only English language validated)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Patel SB, Poston JT, Pohlman A, Hall JB, Kress JP. Rapidly reversible, sedation-related delirium versus persistent delirium in the intensive care unit. Am J Respir Crit Care Med. 2014 Mar 15;189(6):658-65. doi: 10.1164/rccm.201310-1815OC.

    PMID: 24423152DERIVED

MeSH Terms

Conditions

DeliriumRespiratory Aspiration

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersRespiration DisordersRespiratory Tract DiseasesPathologic Processes

Study Officials

  • John P Kress, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 12, 2009

Study Start

June 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

US(1)