AGICOHORT: Prognosis of Patients Who Presented With a State of Extreme Agitation.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Number of deceased patients [6 months]
The 6-month prognosis of patients who presented with extreme agitation in the emergency room.
Secondary Outcome Measures
- Assess the characteristics of agitated patients regarding the age [6 months]
Age
- Assess the characteristics of agitated patients regarding the gender [6 months]
Gender
- Assess the characteristics of agitated patients regarding the mode of arrival in the emergency room [6 months]
Mode of arrival in the emergency room
- Assess the characteristics of agitated patients regarding medical history [6 months]
Medical history
- Assess the characteristics of agitated patients regarding vital signs (blood pressure) [6 months]
Blood pressure
- Assess the characteristics of agitated patients regarding vital signs (oxygen saturation) [6 months]
Oxygen saturation
- Assess the characteristics of agitated patients regarding vital signs (heart rate) [6 months]
Heart rate
- Assess the characteristics of agitated patients regarding vital signs (respiratory rate) [6 months]
Respiratory rate
- Assess the characteristics of agitated patients regarding vital signs (temperature) [6 months]
Temperature
- Assess the characteristics of agitated patients regarding vital signs (Glasgow coma scale) [6 months]
Glasgow 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 months]
Corrected QT interval (QTc)
- Assess the characteristics of agitated patients regarding patient biology (blood ionogram) [6 months]
Blood ionogram
- Assess the characteristics of agitated patients regarding patient biology (urine and blood toxins) [6 months]
Urine and blood toxins
- Assess the characteristics of agitated patients regarding patient biology [6 months]
Arterial blood gas
- Assess the characteristics of agitated patients regarding patient biology (Complete blood count) [6 months]
Complete blood count (CBC)
- Assess the characteristics of agitated patients regarding agitation (RASS) [6 months]
Agitation 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 months]
Agitation 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 months]
Agitation 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 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
- Characterize the management of patients in extreme agitation according to initial pharmacological treatments administered [6 months]
Initial pharmacological treatments administered
- Characterize the management of patients in extreme agitation according to the need for physical restraints [6 months]
Need for physical restraints
- Characterize the management of patients in extreme agitation according to the eed for upper airway protection with intubation [6 months]
Need for upper airway protection with intubation
- Assess the efficacy of the pharmacological treatments administered (GCI S) [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
- Assess the efficacy of the non-pharmacological treatments administered (RASS) [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
- Assess the efficacy of the non-pharmacological treatments administered (BARS) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Agitated patient with the presence of three major criteria, namely,
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restlessness
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insensitivity to pain
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tachypnea (fr>20)
and the presence of a minor criterion among
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sweating
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skin hyperthermia
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non-compliance with law enforcement
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tirelessness
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unusual strength
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inappropriate clothing, nudity
Exclusion Criteria:
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patient age < 18 years
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head trauma
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pregnancy
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detained
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other obvious causes of pain leading to restlessness (renal colic, migraines, etc.)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Avicenne Hospital - Aphp | Bobigny | Ile De France | France | 93000 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- Lariboisière-Saint Louis clinical research unit
Investigators
- Principal Investigator: Frédéric Adnet, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P220382