NCT05807555 Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children
| NCT ID | NCT05807555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-03-29 |
| Primary Completion | 2025-01-01 |
Trial Parameters
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Brief Summary
The Autonomic Nervous System (ANS) regulates the inflammatory response in real time, just as it controls heart rate and other vital functions. Many studies have investigated induced stimulation of the vagus nerve and its therapeutic effect in inhibiting TNFα (Tumor Necrosis Factor alpha) secretion, and therefore the risk of hypotension, septic shock, organ dysfunction during inflammation. While the anti-inflammatory effect of the autonomic nervous system on inflammation has been well studied, conversely, the effect of major inflammation on the balance of the autonomic nervous system is more difficult to understand. The inflammatory reflex could be overwhelmed and the regulatory centers of the brainstem dysregulated during situations of extreme inflammation.
Eligibility Criteria
Inclusion Criteria for cases group : * Hospitalization in a pediatric intensive care unit. * Presenting the sepsis criteria * Patient affiliated or entitled to a social security scheme * Holders of parental authority having received informed information about the study and having signed the consent form Exclusion Criteria for cases group : * Parents or legal guardians who do not speak French * Chronic or acute pathology that can alter autonomic balance (congenital heart disease, encephalopathy, neuropathy, acute pain, etc.) * Recent general anesthesia less than 48 hours old. (inclusion may be made beyond 48 hours from the last general anesthesia if the inclusion criteria remain present) * Taking treatments that can alter the ANS (β-blockers, etc.) or inflammation (NSAIDs, corticosteroids) Inclusion criteria for control group : * Patient affiliated or entitled to a social security scheme * Holders of parental authority having received informed information about the study and having sign