Prognosis of Anxiety in Intensive Care Unit

Anxiety Clinical Trial

— PAN-ICU  

Official title:

Prognosis of Anxiety in Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02355626
• Other study ID #: 12-PANICU
• Status: Completed
• Start date: April 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Locations

Country	Name	City	State
France	General intensive care unit Raymond Poincaré Hospital	Garches	Hauts-de-seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of death or organ failure.		7 days
Secondary	1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)		7 days
Secondary	Severity of an ongoing organ failure (maximum SOFA score)		7 days
Secondary	Assessment of anxiety according to State Trait Anxiety Inventory score (STAI)		7 days
Secondary	Assessment of anxiety according to REAX score		7 days
Secondary	Assessment of anxiety according to the Visual Analog Scale (VAS)		7 days
Secondary	Assessment of Geriatric Anxiety Inventory score (GAI)		7 days