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临床试验/NCT05632419
NCT05632419招募中不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 608 人开始时间: 2023年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
608
试验地点
1
主要终点
Number of deceased patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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
  • skin hyperthermia
  • non-compliance with law enforcement
  • tirelessness
  • unusual strength
  • inappropriate clothing, nudity

排除标准

  • patient age < 18 years
  • head trauma
  • pregnancy
  • other obvious causes of pain leading to restlessness (renal colic, migraines, etc.)

结局指标

主要结局

Number of deceased patients

时间窗: 6 months

The 6-month prognosis of patients who presented with extreme agitation in the emergency room.

次要结局

  • Characterize the management of patients in extreme agitation according to initial pharmacological treatments administered(6 months)
  • Assess the characteristics of agitated patients regarding vital signs (Corrected QT interval on electrocardiogram)(6 months)
  • Assess the characteristics of agitated patients regarding the age(6 months)
  • Assess the characteristics of agitated patients regarding medical history(6 months)
  • Assess the characteristics of agitated patients regarding vital signs (oxygen saturation)(6 months)
  • Assess the characteristics of agitated patients regarding vital signs (heart rate)(6 months)
  • Assess the characteristics of agitated patients regarding patient biology (blood ionogram)(6 months)
  • Assess the characteristics of agitated patients regarding patient biology (urine and blood toxins)(6 months)
  • Assess the characteristics of agitated patients regarding patient biology(6 months)
  • Assess the characteristics of agitated patients regarding patient biology (Complete blood count)(6 months)
  • Assess the characteristics of agitated patients regarding agitation (BARS)(6 months)
  • Assess the characteristics of agitated patients regarding agitation (CGI S)(6 months)
  • Assess the characteristics of agitated patients regarding the gender(6 months)
  • Assess the characteristics of agitated patients regarding the mode of arrival in the emergency room(6 months)
  • Assess the characteristics of agitated patients regarding vital signs (temperature)(6 months)
  • Assess the characteristics of agitated patients regarding vital signs (Glasgow coma scale)(6 months)
  • Assess the characteristics of agitated patients regarding vital signs (blood pressure)(6 months)
  • Assess the characteristics of agitated patients regarding vital signs (respiratory rate)(6 months)
  • Assess the characteristics of agitated patients regarding agitation (RASS)(6 months)
  • Characterize the etiologies of this syndrome (organic, psychiatric or iatrogenic)(6 months)
  • Characterize the management of patients in extreme agitation according to the need for physical restraints(6 months)
  • Characterize the management of patients in extreme agitation according to the eed for upper airway protection with intubation(6 months)
  • Assess the efficacy of the pharmacological treatments administered (GCI S)(6 months)
  • Assess the efficacy of the non-pharmacological treatments administered (RASS)(6 months)
  • Assess the efficacy of the non-pharmacological treatments administered (BARS)(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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