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OpenTrials
Completed

NCT Number: NCT02355626

Prognosis of Anxiety in Intensive Care Unit

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.

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Key information

Conditions

Anxiety Aberrant Motor Behavior in Dementia Anxiety Disorders Behavior Behavioral Symptoms Confusion Delirium Dyskinesias Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General intensive care unit Raymond Poincaré Hospital

Garches, Hauts-de-seine, 92380, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Occurrence of death or organ failure.

    Time frame: 7 days

Secondary outcomes

  1. 1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)

    Time frame: 7 days

  2. Severity of an ongoing organ failure (maximum SOFA score)

    Time frame: 7 days

  3. Assessment of anxiety according to State Trait Anxiety Inventory score (STAI)

    Time frame: 7 days

  4. Assessment of anxiety according to REAX score

    Time frame: 7 days

  5. Assessment of anxiety according to the Visual Analog Scale (VAS)

    Time frame: 7 days

  6. Assessment of Geriatric Anxiety Inventory score (GAI)

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: PAN-ICU

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 4, 2015
Registry last updated
Sep 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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