Prognosis of Patients Who Presented With a State of Extreme Agitation. (AGICOHORT)

March 5, 2024 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

608

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Ile De France
      • Bobigny, Ile De France, France, 93000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Agitated patients

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of deceased patients
Time Frame: 6 months
The 6-month prognosis of patients who presented with extreme agitation in the emergency room.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the characteristics of agitated patients regarding the age
Time Frame: 6 months
Age
6 months
Assess the characteristics of agitated patients regarding the gender
Time Frame: 6 months
Gender
6 months
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
6 months
Assess the characteristics of agitated patients regarding medical history
Time Frame: 6 months
Medical history
6 months
Assess the characteristics of agitated patients regarding vital signs (blood pressure)
Time Frame: 6 months
Blood pressure
6 months
Assess the characteristics of agitated patients regarding vital signs (oxygen saturation)
Time Frame: 6 months
Oxygen saturation
6 months
Assess the characteristics of agitated patients regarding vital signs (heart rate)
Time Frame: 6 months
Heart rate
6 months
Assess the characteristics of agitated patients regarding vital signs (respiratory rate)
Time Frame: 6 months
Respiratory rate
6 months
Assess the characteristics of agitated patients regarding vital signs (temperature)
Time Frame: 6 months
Temperature
6 months
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).
6 months
Assess the characteristics of agitated patients regarding vital signs (Corrected QT interval on electrocardiogram)
Time Frame: 6 months
Corrected QT interval (QTc)
6 months
Assess the characteristics of agitated patients regarding patient biology (blood ionogram)
Time Frame: 6 months
Blood ionogram
6 months
Assess the characteristics of agitated patients regarding patient biology (urine and blood toxins)
Time Frame: 6 months
Urine and blood toxins
6 months
Assess the characteristics of agitated patients regarding patient biology
Time Frame: 6 months
Arterial blood gas
6 months
Assess the characteristics of agitated patients regarding patient biology (Complete blood count)
Time Frame: 6 months
Complete blood count (CBC)
6 months
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)
6 months
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)
6 months
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)
6 months
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
6 months
Characterize the management of patients in extreme agitation according to initial pharmacological treatments administered
Time Frame: 6 months
Initial pharmacological treatments administered
6 months
Characterize the management of patients in extreme agitation according to the need for physical restraints
Time Frame: 6 months
Need for physical restraints
6 months
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
6 months
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
6 months
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Lariboisière-Saint Louis clinical research unit

Investigators

  • Principal Investigator: Frédéric Adnet, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2023

Primary Completion (Estimated)

January 17, 2025

Study Completion (Estimated)

January 17, 2025

Study Registration Dates

First Submitted

October 28, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P220382

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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