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Oxytocin

Pitocin, Syntocinon

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Studies 93
Trials 100
Unknown OBSERVATIONAL NCT04530214

Predictive Elements of Trauma and Its After-effects: Importance of the Quality of Neurobiological Response to Stress

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: Blood collection
Type: OTHER
Description: Blood collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)
Name: Saliva collection
Type: OTHER
Description: Saliva collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)
Name: Electrocardiography (ECG)
Type: OTHER
Description: Electrocardiography (ECG) at enrollment (24-72h following surgery) and at Visit 1 (45-60 days following surgery) to assess heart rate variability
Name: Questionnaires
Type: BEHAVIORAL
Description: Mental health assessment through questionnaires at enrollment (24-72h following surgery), at Visit 1 (45-60 days following surgery), at Visit 2 (7 months following surgery) and at Visit 3 (12 months following surgery)

Primary Outcomes

Measure: Occurrence of depression
TimeFrame: 12 months following surgery
Description: Screening for depression will be done using a validated self-report questionnaire, the Geriatric Depression Scale Short Version (GDS). We will use the threshold value of 10 (score \> or =) which corresponds to a very high probability of depression.
Measure: Occurrence of "psychosomatic death"
TimeFrame: 12 months following surgery
Description: The diagnosis of "psychosomatic death" will be made by a physician. There is no consensus on the diagnosis of this syndrome. However, a patient with "psychosomatic death" is likely to be hospitalized or followed up medically and will not be able to respond to the investigator's request for a telephone interview.
Measure: Occurrence of death
TimeFrame: 12 months following surgery
Description: Vital status will be collected from the participant's family or referring physician or at the birth \& death record service (of the participant's town)

Trial Information

NCT ID

NCT04530214

Status

Unknown

Study Type

OBSERVATIONAL

Sponsor

Direction Centrale du Service de Santé des Armées

Last Updated

December 15, 2025

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