Prognosis of Patients Who Presented With a State of Extre... | NCT05632419

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

NCT05632419

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Recruiting

Last Update Posted

Apr 4, 2025Actual

Enrollment

608Estimated

Phase

Not provided

Conditions

Emergence Delirium

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2023Actual

Primary Completion Date

Jan 17, 2027Estimated

Completion Date

Jan 17, 2027Estimated

First Submitted Date

Oct 28, 2022

First Submission Date that Met QC Criteria

Nov 21, 2022

First Posted Date

Nov 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2025

Last Update Posted Date

Apr 4, 2025Actual

Name	Class
Lariboisière-Saint Louis clinical research unit	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

608Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Assess the characteristics of agitated patients regarding the age	Age	6 months
Assess the characteristics of agitated patients regarding the gender	Gender

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Agitated patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Frédéric Adnet, MD, PhD	Contact	01 48 96 44 08		frederic.adnet@avc.aphp.fr
Eric Vicaut, MD, PhD	Contact	01.40.05.49.73		sec.urc@lrb.aphp.fr

Overall Officials

Name	Affiliation	Role
Frédéric Adnet, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avicenne Hospital - Aphp	Recruiting	Bobigny	Île-de-France Region	93000	France

Condition Browse Module

MeSH Terms

ID	Term
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided