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Emergence DeliriumAGICOHORTNCT05632419

Prognosis of Patients Who Presented With a State of Extreme Agitation.

An observational study of Emergence Delirium, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main objective is to assess the 6-month prognosis of patients who presented with extreme agitation in the emergency room. The primary endpoint is the 6-month mortality of agitated patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Emergence Delirium
How many people
608 participants
Where
1 siteFrance
Study dates
17 Jan 2023to 17 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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: Agitated patients

Who may be able to join

  • Agitated patient with the presence of three major criteria, namely,
  • restlessness
  • insensitivity to pain
  • tachypnea (fr>20)
  • and the presence of a minor criterion among
  • sweating
Show all 11Show fewer
  • skin hyperthermia
  • non-compliance with law enforcement
  • tirelessness
  • unusual strength
  • inappropriate clothing, nudity

Who cannot join

  • patient age < 18 years
  • head trauma
  • pregnancy
  • detained
  • other obvious causes of pain leading to restlessness (renal colic, migraines, etc.)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Frédéric Adnet, MD, PhD contact

01 48 96 44 08

frederic.adnet@avc.aphp.fr

Eric Vicaut, MD, PhD contact

01.40.05.49.73

sec.urc@lrb.aphp.fr

France1 site, 1 recruiting

  • Avicenne Hospital - Aphp

    Bobigny, Île-de-France Region, 93000

    Frédéric ADNET, MD, PhD, + 33 1 48 96 44 08, frederic.adnet@avc.aphp.fr

    Sabine GUINEMER, MD, + 33 6 27 67 19 20, sabine.guinemer@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Assess the 6-month Prognosis of Patients Who Presented With a State of Extreme Agitation: "Excited Delirium Syndrome" AGICOHORT

The main objective is to assess the 6-month prognosis of patients who presented with extreme agitation in the emergency room.

The primary endpoint is the 6-month mortality of agitated patients.

Read the detailed description

Emergency services are confronted with emergency situations characterized by patients who are victims of significant agitation, in particular states of extreme agitation "excited delirium syndrome", which is constantly increasing and which seems to be associated with morbidity and mortality not negligible.

Patients meeting the inclusion and non-inclusion criteria are included on admission to the emergency room.

An evaluation at H1 and at the end of hospitalization is carried out. The patient is contacted by telephone at M1, M3 and M6.

The inclusion period is 24 months The duration of participation (treatment + follow-up) is 6 months The total duration is 30 months.

The research is multicentric and national with the participation of 8 centres.

Medical subject headings
Emergence Delirium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of deceased patients

    The 6-month prognosis of patients who presented with extreme agitation in the emergency room.

    Measured: 6 months

Secondary outcomes (25)

  1. Assess the characteristics of agitated patients regarding the age

    Age

    Measured: 6 months

  2. Assess the characteristics of agitated patients regarding the gender

    Gender

    Measured: 6 months

  3. Assess the characteristics of agitated patients regarding the mode of arrival in the emergency room

    Mode of arrival in the emergency room

    Measured: 6 months

  4. Assess the characteristics of agitated patients regarding medical history

    Medical history

    Measured: 6 months

  5. Assess the characteristics of agitated patients regarding vital signs (blood pressure)

    Blood pressure

    Measured: 6 months

  6. Assess the characteristics of agitated patients regarding vital signs (oxygen saturation)

    Oxygen saturation

    Measured: 6 months

  7. Assess the characteristics of agitated patients regarding vital signs (heart rate)

    Heart rate

    Measured: 6 months

  8. Assess the characteristics of agitated patients regarding vital signs (respiratory rate)

    Respiratory rate

    Measured: 6 months

  9. Assess the characteristics of agitated patients regarding vital signs (temperature)

    Temperature

    Measured: 6 months

  10. Assess the characteristics of agitated patients regarding vital signs (Glasgow coma scale)

    Glasgow coma scale (The GCS is scored between 3 and 15, 3 being the worst and 15 the best).

    Measured: 6 months

  11. Assess the characteristics of agitated patients regarding vital signs (Corrected QT interval on electrocardiogram)

    Corrected QT interval (QTc)

    Measured: 6 months

  12. Assess the characteristics of agitated patients regarding patient biology (blood ionogram)

    Blood ionogram

    Measured: 6 months

  13. Assess the characteristics of agitated patients regarding patient biology (urine and blood toxins)

    Urine and blood toxins

    Measured: 6 months

  14. Assess the characteristics of agitated patients regarding patient biology

    Arterial blood gas

    Measured: 6 months

  15. Assess the characteristics of agitated patients regarding patient biology (Complete blood count)

    Complete blood count (CBC)

    Measured: 6 months

  16. Assess the characteristics of agitated patients regarding agitation (RASS)

    Agitation assessment scale (Richmond Agitation Sedation Scale, RASS) (-5 = worse outcome to +4 = worse outcome, 0 is the better outcome)

    Measured: 6 months

  17. Assess the characteristics of agitated patients regarding agitation (BARS)

    Agitation assessment scale (Behavioural Activity Rating Scale, BARS) (1 = worse outcome to 7 = worse outcome , 4 is the better outcome)

    Measured: 6 months

  18. Assess the characteristics of agitated patients regarding agitation (CGI S)

    Agitation assessment scale (Clinical Global Impression Severity or CGI S, 0 = Not evaluated to 7 = worse outcome)

    Measured: 6 months

  19. Characterize the etiologies of this syndrome (organic, psychiatric or iatrogenic)

    Organic

    • medical background,
    • somatic etiology research with intrinsic imputability criteria (chronological and semiological) and extrinsic (literature)
    • capillary blood glucose, temperature, Glasgow, electrocardiogram
    • blood ionogram, arterial blood gas, blood count Iatrogenic
    • analytical by means of a urinary and blood toxin screening for recent consumptions of psychoactive substances
    • search the treatment of the patient psychiatric
    • clinical observations obtained during consultation

    Measured: 6 months

  20. Characterize the management of patients in extreme agitation according to initial pharmacological treatments administered

    Initial pharmacological treatments administered

    Measured: 6 months

  21. Characterize the management of patients in extreme agitation according to the need for physical restraints

    Need for physical restraints

    Measured: 6 months

  22. Characterize the management of patients in extreme agitation according to the eed for upper airway protection with intubation

    Need for upper airway protection with intubation

    Measured: 6 months

  23. Assess the efficacy of the pharmacological treatments administered (GCI S)

    According to agitation scale at H1, H2 (Clinical Global Impression Severity or CGI S, 0 = Not evaluated to 7 = worse outcome) and need for other pharmacological treatments

    Measured: 6 months

  24. Assess the efficacy of the non-pharmacological treatments administered (RASS)

    According to agitation scale at H1, H2 (Richmond Agitation Sedation Scale, RASS) (-5 = worse outcome to +4 = worse outcome, 0 is the better outcome) and need for other non-pharmacological treatments

    Measured: 6 months

  25. Assess the efficacy of the non-pharmacological treatments administered (BARS)

    According to agitation scale at H1, H2 (Behavioural Activity Rating Scale, BARS) (1 = worse outcome to 7 = worse outcome , 4 is the better outcome) and need for other non-pharmacological treatments

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start17 Jan 2023
  3. Primary completion17 Jan 2027 (estimated)
  4. Study completion17 Jan 2027 (estimated)

Resources

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
608 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05632419
Sponsor's protocol ID
P220382
Acronym
AGICOHORT
Status last verified
Apr 2025
First submitted
28 Oct 2022
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Emergence Delirium, 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 11 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frédéric Adnet, MD, PhD (01 48 96 44 08, frederic.adnet@avc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of deceased patients (time frame: 6 months). 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 NCT05632419.

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 4 Apr 2025.

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