Prognosis of Anxiety in Intensive Care Unit

NCT ID: NCT02355626

Last Updated: 2018-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

391 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Multicentre prospective study. Demographic data, diagnosis, severity scores and vital signs will be assessed at admission.

Within the first 12 hours, and at day 4 and day 7, anxiety will be assessed by the STAI scale, Geriatric Anxiety Inventory (GAI) scale, and a specific questionnaire assessing anxiety in the intensive care (REAX). Visual Analogue Scale (VAS) scoring for anxiety, starvation, thirst, pain and dyspnoea will be collected daily. Anxiety and depression will be evaluated by the Hospital Anxiety and Depression Scale (HADS) on day 7. Patients will be assessed by psychologists or trained doctors, the team in charge of the patient will not be aware of the result of this evaluation.

Clinical and biological data regarding the hemodynamic, neurological, respiratory and renal status will be collected from admission to day 7, as well as parameters required for computing the Sequential Organ Failure Assessment (SOFA) score.

Conditions

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Anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Tarek Sharshar

Tarek SHARSHAR, MD, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarek Sharshar, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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General intensive care unit Raymond Poincaré Hospital

Garches, Hauts-de-seine, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 38161174 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32931190 (View on PubMed)

Other Identifiers

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12-PANICU

Identifier Type: -

Identifier Source: org_study_id

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