AnxietyPAN-ICUNCT02355626
Prognosis of Anxiety in Intensive Care Unit
An observational study of Anxiety, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- How many people
- 391 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients, not comatose and not confused
Who may be able to join
- All adult patients admitted to the ICU
- Patient without delirium at admission (assessed using the CAM-ICU score)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
General intensive care unit Raymond Poincaré Hospital
Garches, Hauts-de-seine, 92380
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Keywords
- Anxiety, level of anxiety, delirium, agitation, tools for measuring anxiety, neuroendocrine system
- Medical subject headings
- Anxiety Disorders, Delirium, Psychomotor Agitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of death or organ failure.
Measured: 7 days
Secondary outcomes (6)
1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)
Measured: 7 days
Severity of an ongoing organ failure (maximum SOFA score)
Measured: 7 days
Assessment of anxiety according to State Trait Anxiety Inventory score (STAI)
Measured: 7 days
Assessment of anxiety according to REAX score
Measured: 7 days
Assessment of anxiety according to the Visual Analog Scale (VAS)
Measured: 7 days
Assessment of Geriatric Anxiety Inventory score (GAI)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Sharshar, Assistance Publique - Hôpitaux de Paris
- Investigators
- Tarek Sharshar, MD, PHD, Principal investigator, General intensive care unit Raymond Poincaré Hospital, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355626
- Sponsor's protocol ID
- 12-PANICU
- Acronym
- PAN-ICU
- Status last verified
- Sep 2018
- First submitted
- 14 Nov 2014
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mazeraud A, Turc G, Sivanandamoorthy S, Porcher R, Stoclin A, Antona M, Polito A, Righy C, Bozza FAB, Siami S, Sharshar T. Association of Lack of Fear of Dying With New Organ Failure: Results of a Multicenter Prospective Cohort Study. Am J Crit Care. 2024 Jan 1;33(1):36-44. doi: 10.4037/ajcc2024517.
PubMed 38161174Mazeraud 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.
PubMed 32931190
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Anxiety in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02355626
- Acronym / sponsor ID
- PAN-ICU / 12-PANICU
- Conditions
- Anxiety
- Keywords
- Anxiety, level of anxiety, delirium, agitation, tools for measuring anxiety, neuroendocrine system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients, not comatose and not confused
Key inclusion criteria (2 listed)
- All adult patients admitted to the ICU
- Patient without delirium at admission (assessed using the CAM-ICU score)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of death or organ failure.
Time frame: 7 days
6 secondary outcomes
1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)
Time frame: 7 days
Severity of an ongoing organ failure (maximum SOFA score)
Time frame: 7 days
Assessment of anxiety according to State Trait Anxiety Inventory score (STAI)
Time frame: 7 days
Assessment of anxiety according to REAX score
Time frame: 7 days
Assessment of anxiety according to the Visual Analog Scale (VAS)
Time frame: 7 days
Assessment of Geriatric Anxiety Inventory score (GAI)
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Derived from this study: PubMed 38161174Mazeraud A, Turc G, Sivanandamoorthy S, Porcher R, Stoclin A, Antona M, Polito A, Righy C, Bozza FAB, Siami S, Sharshar T. Association of Lack of Fear of Dying With New Organ Failure: Results of a Multicenter Prospective Cohort Study. Am J Crit Care. 2024 Jan 1;33(1):36-44. doi: 10.4037/ajcc2024517.
- Derived from this study: PubMed 32931190Mazeraud 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Sharshar, MD, PHD principal investigator
General intensive care unit Raymond Poincaré Hospital, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of death or organ failure. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02355626, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.