Clinical trial NCT02355626: Prognosis of Anxiety in Intensive Care Unit
Official title: Prognosis of Anxiety in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Keywords: Anxiety
level of anxiety
delirium
agitation
tools for measuring anxiety
neuroendocrine system
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ICU patients, not comatose and not confused

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of death or organ failure.
timeFrame: 7 days
Secondary outcomes:
measure: 1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)
timeFrame: 7 days
measure: Severity of an ongoing organ failure (maximum SOFA score)
timeFrame: 7 days
measure: Assessment of anxiety according to State Trait Anxiety Inventory score (STAI)
timeFrame: 7 days
measure: Assessment of anxiety according to REAX score
timeFrame: 7 days
measure: Assessment of anxiety according to the Visual Analog Scale (VAS)
timeFrame: 7 days
measure: Assessment of Geriatric Anxiety Inventory score (GAI)
timeFrame: 7 days
Other outcomes:
Locations:
city: Garches
country: France
facility: General intensive care unit Raymond Poincaré Hospital
state: Hauts-de-seine
Study officials:
affiliation: General intensive care unit Raymond Poincaré Hospital, 92380 Garches, France
name: Tarek Sharshar, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.