Prognosis of Anxiety in Intensive Care Unit

Completed

• Conditions: Anxiety

• Registration Number: NCT02355626
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-14
• Study First Submitted QC: 2015-02-03
• Study First Posted: 2015-02-04
• Primary Completion: 2017-10
• Study Completion: 2017-12
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of death or organ failure.	7 days

Secondary Outcome Measures

Name	Time	Method
Severity of an ongoing organ failure (maximum SOFA score)	7 days
1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)	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 Geriatric Anxiety Inventory score (GAI)	7 days
Assessment of anxiety according to the Visual Analog Scale (VAS)	7 days

Trial Locations

Locations (1)

General intensive care unit Raymond Poincaré Hospital; 🇫🇷 Garches, Hauts-de-seine, France