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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06235008
Other study ID # 2020PI059
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 31, 2024
Est. completion date September 30, 2030

Study information

Verified date January 2024
Source Central Hospital, Nancy, France
Contact GIRERD Nicolas
Phone 0383157322
Email n.girerd@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational retrospective multi-center study in patients managed for acute dyspnea by Emergency department medical team. The main aim of the study is to evaluate factors associated with mortality risks in patients managed for acute dyspnea by an Emergency department medical team, overall, as well as in subgroups of interest (male/female, age categories, mode of admission and comorbidities).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75000
Est. completion date September 30, 2030
Est. primary completion date March 31, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Man or women = 18 years - Patients with acute dyspnea cared by a medical team of the emergencies of CHRU of Nancy, CHR Metz-Thionville and CH d'Epinal. Exclusion Criteria: - Cardiorespiratory arrest before medical management by the Emergency Department team - Adults under legal protection

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU Nancy

Sponsors (1)

Lead Sponsor Collaborator
Pr. Nicolas GIRERD

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause mortality Within 5 years following hospital discharge
Secondary Main diagnosis during the initial hospitalization Within hospital stay, maximum 21 days
Secondary Mismatch between diagnosis in the Emergency department and at discharge Difference between the diagnosis reported in the Emergency department file and the diagnosis reported at hospital discharge. Within hospital stay, maximum 21 days
Secondary Length of hospital stay Within hospital stay, maximum 21 days
Secondary Administration of non-invasive ventilation Within hospital stay, maximum 21 days
Secondary Timing of non-invasive ventilation Within hospital stay, maximum 21 days
Secondary Administration of diuretics Within hospital stay, maximum 21 days
Secondary Timing of diuretics Within hospital stay, maximum 21 days
Secondary Post emergency admission Type of department admitting the patient following emergency care (intensive care unit, cardiology unit, cardiac intensive care unit, post-emergency department, other...) Within hospital stay, maximum 21 days
Secondary All-cause hospital mortality Within hospital stay, maximum 30 days
Secondary Readmissions (all-cause and related to acute dyspnea) to the emergency department Within 5 years after admission
Secondary Congestion score Assessed by: Congestion score assessed on chest X-ray on admission to the emergency department. The congestion score ranges from 0 (indicating no congestion signs) to 3 (indicating intense congestion). Within 2 days of admission
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