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NCT Number: NCT06523127

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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Jérôme MOREL, MD PhD

SUB_INVESTIGATOR

Marie DAKENG, resident

CONTACT

[email protected]

(0)4 77 82 83 29 ext. +33

Marie DAKENG, resident

PRINCIPAL_INVESTIGATOR

Nory ELHADJENE, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Patients:

  • death in 2024,
  • refusal by patient or relative.

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. International survey among neurointensivists from ANARLF network - questionnaires

    Time frame: Month : 3

    Comparison of the number of decisions of withholding treatment in the clinical cases versus real life

  2. International survey among neurointensivists from ANARLF network - follow-up

    Time frame: Month : 3

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie DAKENG, resident

CONTACT

[email protected]

(0)4 77 82 83 29 ext. +33

Nory ELHADJENE, MD

CONTACT

[email protected]

(0)4 77 82 83 29 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Withholding of Life-sustaining Treatment and Quality of Life After Severe Acute Brain Injury: Qualitative Analysis and Ethical Issues.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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