NCT02355626

Brief Summary

Anxiety is commonly considered as an epiphenomenon of the cognitive and emotional response to a threat. Anxiety is a consequence of the reciprocal interaction between stress and the neuroendocrine, autonomic and immune systems. A systematic and circumstantial assessment of anxiety in critically ill patients has never been done. Our hypothesis is that high levels of anxiety at ICU admission are associated with death or the occurrence of one or more organ failure during the first 7 days, and that anxiety should be considered as a "warning sign" in critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
391

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

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

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2018

Enrollment Period

3.5 years

First QC Date

November 14, 2014

Last Update Submit

September 13, 2018

Conditions

Anxiety

Keywords

Anxietylevel of anxietydeliriumagitationtools for measuring anxietyneuroendocrine system

Outcome Measures

Primary Outcomes (1)

  • Occurrence of death or organ failure.

    7 days

Secondary Outcomes (6)

  • 1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)

    7 days

  • Severity of an ongoing organ failure (maximum SOFA score)

    7 days

  • Assessment of anxiety according to State Trait Anxiety Inventory score (STAI)

    7 days

  • Assessment of anxiety according to REAX score

    7 days

  • Assessment of anxiety according to the Visual Analog Scale (VAS)

    7 days

  • +1 more secondary outcomes

Eligibility Criteria

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

ICU patients, not comatose and not confused

You may qualify if:

  • All adult patients admitted to the ICU
  • Patient without delirium at admission (assessed using the CAM-ICU score)

You may not qualify if:

  • Severe hearing impairment or poor understanding of French language
  • History of serious psychiatric illness
  • Comatose or sedated patient at admission
  • Diagnosis of voluntary self-poisoning, or polytrauma at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General intensive care unit Raymond Poincaré Hospital

Garches, Hauts-de-seine, 92380, France

Location

Related Publications (2)

  • Mazeraud A, Turc G, Sivanandamoorthy S, Porcher R, Stoclin A, Antona M, Polito A, Righy C, Bozza FAB, Siami S, Sharshar T. Association of Lack of Fear of Dying With New Organ Failure: Results of a Multicenter Prospective Cohort Study. Am J Crit Care. 2024 Jan 1;33(1):36-44. doi: 10.4037/ajcc2024517.

    PMID: 38161174DERIVED

  • Mazeraud A, Polito A, Sivanandamoorthy S, Porcher R, Heming N, Stoclin A, Hissem T, Antona M, Blot F, Gaillard R, Chretien F, Annane D, Bozza FAB, Siami S, Sharshar T; Groupe d'Explorations Neurologiques en Reanimation (GENER). Association Between Anxiety and New Organ Failure, Independently of Critical Illness Severity and Respiratory Status: A Prospective Multicentric Cohort Study. Crit Care Med. 2020 Oct;48(10):1471-1479. doi: 10.1097/CCM.0000000000004495.

    PMID: 32931190DERIVED

MeSH Terms

Conditions

Anxiety DisordersDeliriumPsychomotor Agitation

Condition Hierarchy (Ancestors)

Mental DisordersConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersDyskinesiasPsychomotor DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehavior

Study Officials

  • Tarek Sharshar, MD, PHD

    General intensive care unit Raymond Poincaré Hospital, 92380 Garches, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tarek SHARSHAR, MD, PHD

Study Record Dates

First Submitted

November 14, 2014

First Posted

February 4, 2015

Study Start

April 1, 2014

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

September 14, 2018

Record last verified: 2018-09

Locations

FR(1)