Clinical trial NCT05632419: Prognosis of Patients Who Presented With a State of Extreme Agitation.
Official title: Assess the 6-month Prognosis of Patients Who Presented With a State of Extreme Agitation: "Excited Delirium Syndrome" AGICOHORT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emergence Delirium
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Lariboisière-Saint Louis clinical research unit
First posted: 2022-11-30
Enrollment: 608
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Agitated patients

Brief 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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Number of deceased patients
timeFrame: 6 months
Secondary outcomes:
measure: Assess the characteristics of agitated patients regarding the age
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding the gender
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding the mode of arrival in the emergency room
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding medical history
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding vital signs (blood pressure)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding vital signs (oxygen saturation)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding vital signs (heart rate)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding vital signs (respiratory rate)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding vital signs (temperature)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding vital signs (Glasgow coma scale)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding vital signs (Corrected QT interval on electrocardiogram)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding patient biology (blood ionogram)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding patient biology (urine and blood toxins)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding patient biology
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding patient biology (Complete blood count)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding agitation (RASS)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding agitation (BARS)
timeFrame: 6 months
measure: Assess the characteristics of agitated patients regarding agitation (CGI S)
timeFrame: 6 months
measure: Characterize the etiologies of this syndrome (organic, psychiatric or iatrogenic)
timeFrame: 6 months
measure: Characterize the management of patients in extreme agitation according to initial pharmacological treatments administered
timeFrame: 6 months
measure: Characterize the management of patients in extreme agitation according to the need for physical restraints
timeFrame: 6 months
measure: Characterize the management of patients in extreme agitation according to the eed for upper airway protection with intubation
timeFrame: 6 months
measure: Assess the efficacy of the pharmacological treatments administered (GCI S)
timeFrame: 6 months
measure: Assess the efficacy of the non-pharmacological treatments administered (RASS)
timeFrame: 6 months
measure: Assess the efficacy of the non-pharmacological treatments administered (BARS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Avicenne Hospital - Aphp
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frédéric Adnet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: