NCT07115719

Brief Summary

Background In France, a significant proportion of end-of-life (EOL) decisions occur in emergency departments (EDs), where time constraints and limited resources may hinder optimal care. Although withholding or withdrawing life-sustaining treatments (WHWD) is common in this context, the impact of timing on patient outcomes remains unclear. Objective: To assess how the timing of WHWD decisions influences short- and long-term outcomes among ED patients. Methods: We conducted a retrospective, observational study at Beaujon Hospital's ED (Paris, France) between January 2020 and December 2021. We included 354 adult patients admitted to the observation unit with a WHWD decision. Patients were categorized into early (eWHWD) and late (lWHWD) groups based on the median time to decision. The primary endpoint was 28-day all-cause mortality. Cox regression was used for survival analysis, adjusting for age, sex, comorbidities, functional status, and severity of illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
354

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3.3 years

First QC Date

August 4, 2025

Last Update Submit

August 4, 2025

Conditions

WITHOLDING WITHDRAWING in End of Life Situation

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    28-days

Interventions

No Intervention: Observational CohortOTHER

NO INTERVENTION

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients in end of life situation with withholding or withdrawing decision

You may qualify if:

  • To be included, patients hospitalised after their ED visit must be admitted to the observation unit (OU) in association with a mention of a withholding/withdrawing of the life-sustaining treatment in the ED medical record.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Beaujon

Clichy, Île-de-France (Paris), 92110, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 11, 2025

Study Start

January 1, 2020

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)