Clinical trial NCT04530214: Predictive Elements of Trauma and Its After-effects: Importance of the Quality of Neurobiological Response to Stress
Official title: Predictive Elements of Trauma and Its After-effects: Importance of the Quality of Neurobiological Response to Stress
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress Reaction
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 130
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the emergency room for a fracture of the upper end of the femur.

Brief summary: The neurobiological response to stress is an adaptive response allowing us to cope with the multiple aggressions of daily life. This response orchestrates the body's systemic reaction. The intensity of response to stress can modify the body's functioning, which implies a variety of fields where biomarkers may be isolated: immunity, psychology, neurophysiology, integrative physiology. When stress is too intense or prolonged, response to stress may become misfitted and deleterious.

This study is based on the hypothesis that a severe physical or psychological trauma is associated with an intense and misfitted stress that is responsible from an undue immuno-inflammatory activation (through sympathetic activation). The result is a subinvasive state of systemic and tissue inflammation (low-noise inflammation), responsible for the mid-term deleterious consequences of the traumatic event.

The objective of this study is to understand how the dysregulation of intense stress simultaneously generates an initial pathological state and an alteration of mid-term evolution (which is considered as a poor prognosis and/or as responsible for after-effects).

The investigators wish to identify relevant biomarkers of the mechanisms activated during intense stress and influencing the immuno-inflammatory and epigenetic spheres with deleterious consequences on physiological and psychological functions.


Eligibility criteria: Inclusion Criteria:

* Fracture of the upper end of the femur
* Cognitive state allowing the understanding of questionnaires

Exclusion Criteria:

* Traumatic Brain Injury
* Chronic inflammatory or immune pathologies
* On anticoagulants
* On neuroleptic or antidepressant treatment
* Pathology or health condition not allowing 1-year survival

Primary outcomes:
measure: Occurrence of depression
timeFrame: 12 months following surgery
measure: Occurrence of "psychosomatic death"
timeFrame: 12 months following surgery
measure: Occurrence of death
timeFrame: 12 months following surgery
Secondary outcomes:
measure: Evolution of heart rate variability between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of perceived stress level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of anxiety level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of post-traumatic stress disorder severity level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of quality of life between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of cortisol level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of GABA level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of oxydative stress level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of BDNF level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of pro and anti-inflammatory cytokines level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of IGF-1 level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of NPY level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of NPS between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of ocytocin level between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of methylation of genes coding for BDNF between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
measure: Evolution of methylation of genes coding for glucocorticoid receptors between enrollment and Visit 1
timeFrame: Between enrollment and Visit 1 (45-60 days following surgery)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Clamart
country: France
facility: Hôpital d'Instruction des Armées Percy
city: Saint-Mandé
country: France
facility: Hôpital d'Instruction des Armées Bégin
city: Toulon
country: France
facility: Hôpital d'Instruction des Armées Sainte-Anne
Study officials:
References: