- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07115719
- Original Trial
Withholding and/or Withdrawing Life-sustaining Treatment on Emergency Department Patients' Short- and Long-term Outcomes
Early Decision Effect of Withholding and/or Withdrawing Life-sustaining Treatment on Emergency Department Patients' Short- and Long-term Outcomes: a Retrospective Analysis.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Île-de-France (Paris)
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Clichy, Île-de-France (Paris), France, 92110
- Hôpital Beaujon
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
all-cause mortality
Time Frame: 28-days
|
28-days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- urgBjNWHWD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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