Prognosis of Anxiety in Intensive Care Unit (PAN-ICU)

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.

Study Overview

• Status: Completed
• Conditions: Anxiety

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 Type: Observational
• Enrollment (Actual): 391

Contacts and Locations

Study Locations

• France
  • Hauts-de-seine
    • Garches, Hauts-de-seine, France, 92380
      • General intensive care unit Raymond Poincaré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ICU patients, not comatose and not confused

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of death or organ failure.	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Assessment of Geriatric Anxiety Inventory score (GAI)	7 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Tarek Sharshar, MD, PHD, General intensive care unit Raymond Poincaré Hospital, 92380 Garches, France

Publications and helpful links

General Publications

• Mazeraud A, Polito A, Sivanandamoorthy S, Porcher R, Heming N, Stoclin A, Hissem T, Antona M, Blot F, Gaillard R, Chrétien F, Annane D, Bozza FAB, Siami S, Sharshar T; Groupe d'Explorations Neurologiques en Réanimation (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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 14, 2014
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 4, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: delirium; Anxiety; agitation; level of anxiety; tools for measuring anxiety; neuroendocrine system
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 12-PANICU