Quality of LifeNCT06523127
Withholding of Life-sustaining Treatment and Quality of Life After Severe Acute Brain Injury: Qualitative Analysis and Ethical Issues
An observational study of Quality of Life and Brain Injuries, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Withdrawal of life-sustaining treatment affects 10-15% of ICU patients, including those with severe acute brain injury, whose care appears futile in terms of prognosis based on clinical and paraclinical data, expected quality of life, patient preferences, age, or reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Brain Injuries, Post ICU
- What is being tested?
- Recording data from the ICU stay and the post-ICU follow-up.
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2024to Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute brain injury admitted to intensive care in 2022 will be included.
Who may be able to join
- Patients:
- with severe acute brain injury (TBI, stroke, central nervous system infection).
- admitted in the neurocritical care unit in 2022.
- followed up 24 months after ICU between 15th April 2024 and 31st August 2024.
Who cannot join
- Patients:
- death in 2024,
- refusal by patient or relative.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Saint Etienne
Saint-Etienne, 42055
Marie DAKENG, resident, (0)4 77 82 83 29 ext. +33, mcgperret@gmail.com
Marie DAKENG, resident
About this study
Official title: Withholding of Life-sustaining Treatment and Quality of Life After Severe Acute Brain Injury: Qualitative Analysis and Ethical Issues.
Withdrawal of life-sustaining treatment affects 10-15% of ICU patients, including those with severe acute brain injury, whose care appears futile in terms of prognosis based on clinical and paraclinical data, expected quality of life, patient preferences, age, or reduced quality of life.
There are few studies on withholding treatment compared with withdrawing treatment, and even fewer on survivors after a decision to withhold treatment.
Read more
Quality of life is defined by WHO as "an individual's perception of his or her position in life in the context of the culture and value systems in which he or she lives and in relation to his or her goals, expectations, standards and concerns". The relationship between quality of life and neurological outcome after severe acute brain injury is controversial and therefore difficult to predict.
That's why the investigators question the legitimacy of making decisions to withhold treatment from patients with severe acute brain injury based on their expected quality of life, when this prediction is uncertain.
- Conditions
- Quality of Life, Brain Injuries, Post ICU
- Being tested
- Recording data from the ICU stay and the post-ICU follow-up.
- Keywords
- Quality of life, Withholding of life-sustaining treatments, Withdrawal of life-sustaining treatment, Severe acute brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recording data from the ICU stay and the post-ICU follow-up.Other
Record analysis of the post-ICU follow-up with the Interpretative Phenomenological Analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe acute brain injury and with withholding of life-sustaining treatment | Assessment of quality of life in patients with severe acute brain injury based on the audio recording during post-ICU follow-up. Receives: Other: Recording data from the ICU stay and the post-ICU follow-up. | |
| Patients with severe acute brain injury and without withholding of life-sustaining treatment | Assessment of quality of life in patients with severe acute brain injury based on the audio recording during post-ICU follow-up. Receives: Other: Recording data from the ICU stay and the post-ICU follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpretative Phenomenological Analysis
Qualitative analysis of the quality of life in patients with severe acute brain injury and with withholding of life-sustaining treatment
Measured: 24 months after ICU discharge
Secondary outcomes (2)
International survey among neurointensivists from ANARLF network - questionnaires
Comparison of the number of decisions of withholding treatment in the clinical cases versus real life
Measured: Month : 3
International survey among neurointensivists from ANARLF network - follow-up
Comparison of the predicted neurological outcome and quality of life by neurointensivists versus the real neurological outcome and quality of life assessed at the post-ICU follow-up.
Measured: Month : 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start3 Jun 2024
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie DAKENG, resident, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523127
- Sponsor's protocol ID
- IRBN672024/CHUSTE
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- 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 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withholding of Life-sustaining Treatment and Quality of Life After Severe Acute Brain Injury: Qualitative Analysis and Ethical Issues.
- ClinicalTrials.gov ID
- NCT06523127
- Acronym / sponsor ID
- IRBN672024/CHUSTE
- Conditions
- Quality of Life, Brain Injuries, Post ICU
- Keywords
- Quality of life, Withholding of life-sustaining treatments, Withdrawal of life-sustaining treatment, Severe acute brain injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 26 Jul 2024 (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.
Withdrawal of life-sustaining treatment affects 10-15% of ICU patients, including those with severe acute brain injury, whose care appears futile in terms of prognosis based on clinical and paraclinical data, expected quality of life, patient preferences, age, or reduced quality of life.
There are few studies on withholding treatment compared with withdrawing treatment, and even fewer on survivors after a decision to withhold treatment.
Quality of life is defined by WHO as "an individual's perception of his or her position in life in the context of the culture and value systems in which he or she lives and in relation to his or her goals, expectations, standards and concerns". The relationship between quality of life and neurological outcome after severe acute brain injury is controversial and therefore difficult to predict.
That's why the investigators question the legitimacy of making decisions to withhold treatment from patients with severe acute brain injury based on their expected quality of life, when this prediction is uncertain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with severe acute brain injury and with withholding of life-sustaining treatment | – | Other: Recording data from the ICU stay and the post-ICU follow-up.Assessment of quality of life in patients with severe acute brain injury based on the audio recording during post-ICU follow-up. |
| Patients with severe acute brain injury and without withholding of life-sustaining treatment | – | Other: Recording data from the ICU stay and the post-ICU follow-up.Assessment of quality of life in patients with severe acute brain injury based on the audio recording during post-ICU follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute brain injury admitted to intensive care in 2022 will be included.
Key inclusion criteria (4 listed)
- with severe acute brain injury (TBI, stroke, central nervous system infection).
- admitted in the neurocritical care unit in 2022.
- followed up 24 months after ICU between 15th April 2024 and 31st August 2024.
Key exclusion criteria (3 listed)
- death in 2024,
- refusal by patient or relative.
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 |
|---|---|---|
| Recording data from the ICU stay and the post-ICU follow-up.Record analysis of the post-ICU follow-up with the Interpretative Phenomenological Analysis | Other | Patients with severe acute brain injury and with withholding of life-sustaining treatment, Patients with severe acute brain injury and without withholding of life-sustaining treatment |
Primary outcome
Interpretative Phenomenological Analysis
Time frame: 24 months after ICU discharge
Qualitative analysis of the quality of life in patients with severe acute brain injury and with withholding of life-sustaining treatment
2 secondary outcomes
International survey among neurointensivists from ANARLF network - questionnaires
Time frame: Month : 3
International survey among neurointensivists from ANARLF network - follow-up
Time frame: Month : 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Marie DAKENG, resident principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Quality of Life and Brain Injuries, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie DAKENG, resident ((0)4 77 82 83 29 ext. +33, mcgperret@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interpretative Phenomenological Analysis (time frame: 24 months after ICU discharge). 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 26 Jul 2024.