NCT05632419

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
608

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jan 2023Jan 2027

First Submitted

Initial submission to the registry

October 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2027

Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

4 years

First QC Date

October 28, 2022

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of deceased patients

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

    6 months

Secondary Outcomes (25)

  • Assess the characteristics of agitated patients regarding the age

    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 medical history

    6 months

  • Assess the characteristics of agitated patients regarding vital signs (blood pressure)

    6 months

  • +20 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Agitated patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avicenne Hospital - Aphp

Bobigny, Île-de-France Region, 93000, France

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Frédéric Adnet, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Adnet, MD, PhD

CONTACT

Eric Vicaut, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2022

First Posted

November 30, 2022

Study Start

January 17, 2023

Primary Completion (Estimated)

January 17, 2027

Study Completion (Estimated)

January 17, 2027

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations