WITHOLDING WITHDRAWING in End of Life SituationNCT07115719
Withholding and/or Withdrawing Life-sustaining Treatment on Emergency Department Patients' Short- and Long-term Outcomes
An observational study of WITHOLDING WITHDRAWING in End of Life Situation, run by Beaujon Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- WITHOLDING WITHDRAWING in End of Life Situation
- How many people
- 354 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients in end of life situation with withholding or withdrawing decision
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
- Being tested
- No Intervention: Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
NO INTERVENTION
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jan 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WITHOLDING WITHDRAWING in End of Life SituationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaujon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prabakar VAITTINADA AYAR, Beaujon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115719
- Sponsor's protocol ID
- urgBjNWHWD
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Decision Effect of Withholding and/or Withdrawing Life-sustaining Treatment on Emergency Department Patients' Short- and Long-term Outcomes: a Retrospective Analysis.
- ClinicalTrials.gov ID
- NCT07115719
- Acronym / sponsor ID
- urgBjNWHWD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Beaujon HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients in end of life situation with withholding or withdrawing decision
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortNO INTERVENTION | Other | – |
Primary outcome
all-cause mortality
Time frame: 28-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of WITHOLDING WITHDRAWING in End of Life Situation, run by Beaujon Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 28-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.