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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05632419
Acronym
AGICOHORT
Enrollment
608
Registered
2022-11-30
Start date
2023-01-17
Completion date
2027-01-17
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium

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.

Interventions

None listed

Sponsors

Lariboisière-Saint Louis clinical research unit
CollaboratorUNKNOWN
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Number of deceased patients6 monthsThe 6-month prognosis of patients who presented with extreme agitation in the emergency room.

Secondary

MeasureTime frameDescription
Assess the characteristics of agitated patients regarding the gender6 monthsGender
Assess the characteristics of agitated patients regarding the mode of arrival in the emergency room6 monthsMode of arrival in the emergency room
Assess the characteristics of agitated patients regarding medical history6 monthsMedical history
Assess the characteristics of agitated patients regarding vital signs (blood pressure)6 monthsBlood pressure
Assess the characteristics of agitated patients regarding vital signs (oxygen saturation)6 monthsOxygen saturation
Assess the characteristics of agitated patients regarding vital signs (heart rate)6 monthsHeart rate
Assess the characteristics of agitated patients regarding vital signs (respiratory rate)6 monthsRespiratory rate
Assess the characteristics of agitated patients regarding vital signs (temperature)6 monthsTemperature
Assess the characteristics of agitated patients regarding vital signs (Glasgow coma scale)6 monthsGlasgow coma scale (The GCS is scored between 3 and 15, 3 being the worst and 15 the best).
Assess the characteristics of agitated patients regarding vital signs (Corrected QT interval on electrocardiogram)6 monthsCorrected QT interval (QTc)
Assess the characteristics of agitated patients regarding patient biology (blood ionogram)6 monthsBlood ionogram
Assess the characteristics of agitated patients regarding patient biology (urine and blood toxins)6 monthsUrine and blood toxins
Assess the characteristics of agitated patients regarding the age6 monthsAge
Assess the characteristics of agitated patients regarding patient biology (Complete blood count)6 monthsComplete blood count (CBC)
Assess the characteristics of agitated patients regarding agitation (RASS)6 monthsAgitation assessment scale (Richmond Agitation Sedation Scale, RASS) (-5 = worse outcome to +4 = worse outcome, 0 is the better outcome)
Assess the characteristics of agitated patients regarding agitation (BARS)6 monthsAgitation assessment scale (Behavioural Activity Rating Scale, BARS) (1 = worse outcome to 7 = worse outcome , 4 is the better outcome)
Assess the characteristics of agitated patients regarding agitation (CGI S)6 monthsAgitation assessment scale (Clinical Global Impression Severity or CGI S, 0 = Not evaluated to 7 = worse outcome)
Characterize the etiologies of this syndrome (organic, psychiatric or iatrogenic)6 monthsOrganic * 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
Characterize the management of patients in extreme agitation according to initial pharmacological treatments administered6 monthsInitial pharmacological treatments administered
Characterize the management of patients in extreme agitation according to the need for physical restraints6 monthsNeed for physical restraints
Characterize the management of patients in extreme agitation according to the eed for upper airway protection with intubation6 monthsNeed for upper airway protection with intubation
Assess the efficacy of the pharmacological treatments administered (GCI S)6 monthsAccording 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
Assess the efficacy of the non-pharmacological treatments administered (RASS)6 monthsAccording 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
Assess the efficacy of the non-pharmacological treatments administered (BARS)6 monthsAccording 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
Assess the characteristics of agitated patients regarding patient biology6 monthsArterial blood gas

Countries

France

Contacts

Primary ContactFrédéric Adnet, MD, PhD
frederic.adnet@avc.aphp.fr01 48 96 44 08
Backup ContactEric Vicaut, MD, PhD
sec.urc@lrb.aphp.fr01.40.05.49.73

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026