Actively Recruiting

Age: 1Day - 17Years
All Genders
Healthy Volunteers
NCT05807555

Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children

Led by Centre Hospitalier Universitaire de Saint Etienne · Updated on 2024-05-03

60

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children

Who Can Participate

Age: 1Day - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized in a pediatric intensive care unit
  • Meets sepsis criteria
  • Covered by a social security scheme
  • Parent or guardian has received study information and signed consent form
  • For control group: Covered by a social security scheme
  • For control group: Parent or guardian has received study information and signed consent form
Not Eligible

You will not qualify if you...

  • Parent or guardian does not speak French
  • Has chronic or acute condition affecting autonomic balance (e.g., congenital heart disease, encephalopathy, neuropathy, acute pain)
  • Received general anesthesia less than 48 hours ago (cases group) or less than 1 month ago (control group)
  • Taking treatments that affect the autonomic nervous system (e.g., beta-blockers) or inflammation (NSAIDs, corticosteroids)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chu de Saint-Etienne

Saint-Etienne, France, 42055

Actively Recruiting

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Research Team

H

HUGUES PATURAL, MD-PHD

CONTACT

M

MARINE DUBOIS, Resident

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children | DecenTrialz