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NCT Number: NCT05632419

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

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.

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Key information

Conditions

Emergence Delirium Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • skin hyperthermia
  • non-compliance with law enforcement
  • tirelessness
  • unusual strength
  • inappropriate clothing, nudity

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Number of deceased patients

    Time frame: 6 months

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

Secondary outcomes

  1. Assess the characteristics of agitated patients regarding the age

    Time frame: 6 months

    Age

  2. Assess the characteristics of agitated patients regarding the gender

    Time frame: 6 months

    Gender

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

    Time frame: 6 months

    Mode of arrival in the emergency room

  4. Assess the characteristics of agitated patients regarding medical history

    Time frame: 6 months

    Medical history

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

    Time frame: 6 months

    Blood pressure

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

    Time frame: 6 months

    Oxygen saturation

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

    Time frame: 6 months

    Heart rate

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

    Time frame: 6 months

    Respiratory rate

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

    Time frame: 6 months

    Temperature

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

    Time frame: 6 months

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

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

    Time frame: 6 months

    Corrected QT interval (QTc)

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

    Time frame: 6 months

    Blood ionogram

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

    Time frame: 6 months

    Urine and blood toxins

  14. Assess the characteristics of agitated patients regarding patient biology

    Time frame: 6 months

    Arterial blood gas

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

    Time frame: 6 months

    Complete blood count (CBC)

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 6 months

    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

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

    Time frame: 6 months

    Initial pharmacological treatments administered

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

    Time frame: 6 months

    Need for physical restraints

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

    Time frame: 6 months

    Need for upper airway protection with intubation

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

    Time frame: 6 months

    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

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

    Time frame: 6 months

    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

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

    Time frame: 6 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Vicaut, MD, PhD

CONTACT

[email protected]

01.40.05.49.73

Frédéric Adnet, MD, PhD

CONTACT

[email protected]

01 48 96 44 08

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Lariboisière-Saint Louis clinical research unit

Registry information

Official study title

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

Acronym: AGICOHORT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 30, 2022
Registry last updated
Apr 4, 2025

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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