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

Emergence Delirium Clinical Trial

— AGICOHORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632419
• Other study ID #: P220382
• Status: Recruiting
• Start date: January 17, 2023
• Est. completion date: January 17, 2025

Study information

• Verified date: March 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Frédéric Adnet, MD, PhD
• Phone: 01 48 96 44 08
• Email: frederic.adnet[@]avc.aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 608
• Est. completion date: January 17, 2025
• Est. primary completion date: January 17, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium

Locations

Country	Name	City	State
France	Avicenne Hospital - Aphp	Bobigny	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Lariboisière-Saint Louis clinical research unit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of deceased patients	The 6-month prognosis of patients who presented with extreme agitation in the emergency room.	6 months
Secondary	Assess the characteristics of agitated patients regarding the age	Age	6 months
Secondary	Assess the characteristics of agitated patients regarding the gender	Gender	6 months
Secondary	Assess the characteristics of agitated patients regarding the mode of arrival in the emergency room	Mode of arrival in the emergency room	6 months
Secondary	Assess the characteristics of agitated patients regarding medical history	Medical history	6 months
Secondary	Assess the characteristics of agitated patients regarding vital signs (blood pressure)	Blood pressure	6 months
Secondary	Assess the characteristics of agitated patients regarding vital signs (oxygen saturation)	Oxygen saturation	6 months
Secondary	Assess the characteristics of agitated patients regarding vital signs (heart rate)	Heart rate	6 months
Secondary	Assess the characteristics of agitated patients regarding vital signs (respiratory rate)	Respiratory rate	6 months
Secondary	Assess the characteristics of agitated patients regarding vital signs (temperature)	Temperature	6 months
Secondary	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).	6 months
Secondary	Assess the characteristics of agitated patients regarding vital signs (Corrected QT interval on electrocardiogram)	Corrected QT interval (QTc)	6 months
Secondary	Assess the characteristics of agitated patients regarding patient biology (blood ionogram)	Blood ionogram	6 months
Secondary	Assess the characteristics of agitated patients regarding patient biology (urine and blood toxins)	Urine and blood toxins	6 months
Secondary	Assess the characteristics of agitated patients regarding patient biology	Arterial blood gas	6 months
Secondary	Assess the characteristics of agitated patients regarding patient biology (Complete blood count)	Complete blood count (CBC)	6 months
Secondary	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)	6 months
Secondary	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)	6 months
Secondary	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)	6 months
Secondary	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	6 months
Secondary	Characterize the management of patients in extreme agitation according to initial pharmacological treatments administered	Initial pharmacological treatments administered	6 months
Secondary	Characterize the management of patients in extreme agitation according to the need for physical restraints	Need for physical restraints	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months