Assessing the prognosis of patients with extreme agitation in the emergency room
Assess the 6-month Prognosis of Patients Who Presented With a State of Extreme Agitation: "Excited Delirium Syndrome" AGICOHORT
This study looks at how patients with extreme agitation in the emergency room, especially those with emergence delirium, do over six months to see how many survive and how they feel afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 608 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Bobigny, Île-de-France Region) |
| Trial ID | NCT05632419 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the 6-month prognosis of patients who present with extreme agitation, specifically focusing on those experiencing emergence delirium. Patients will be assessed upon admission to the emergency room and followed up at one, three, and six months post-discharge to determine mortality rates. The study involves multiple centers across France and will include a total participation duration of six months for each patient. The research seeks to understand the morbidity and mortality associated with excited delirium syndrome.
Who should consider this trial
Good fit: Ideal candidates for this study are adults presenting with extreme agitation characterized by specific clinical criteria.
Not a fit: Patients under 18 years of age, those with head trauma, pregnancy, or other obvious causes of agitation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the prognosis of agitated patients, potentially leading to improved management strategies in emergency settings.
How similar studies have performed: While the specific approach of this study may be novel, there is a growing body of literature addressing the outcomes of patients with extreme agitation, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Bobigny, Île-de-France Region
- Avicenne Hospital - Aphp — Bobigny, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Frédéric Adnet, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Frédéric Adnet, MD, PhD
- Email: frederic.adnet@avc.aphp.fr
- Phone: 01 48 96 44 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.