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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-29

Study Completion Date

2025-01-01

Brief Summary

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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.

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Detailed Description

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The purpose of this study is to follow the short-term evolution of sympathetic and parasympathetic markers of dysautonomia in children hospitalized in intensive care units for severe sepsis, to characterize the evolution of the different autonomic indices according to the site of infection (meningitis, pulmonary infection, organ failure, bacteraemia) and types of pathogens (viral, bacterial, atypical germs) and correlating the evolution of the various inflammation biomarkers and cytokines with the degree of dysautonomia.

Conditions

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Sepsis Autonomic Nervous System

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Infant with sepsis (Case)

Patient hospitalized in the pediatric intensive care unit (ICU) for severe sepsis

Ambulatory ECG

Intervention Type OTHER

24h ECG monitoring

Blood sample

Intervention Type BIOLOGICAL

The usual biological tests necessary for the management of the child and the addition of 1 tube of 2 ml

Healthy child of the same sex and age (Control)

Healthy children will be matched to cases by age and gender

Ambulatory ECG

Intervention Type OTHER

24h ECG monitoring

Interventions

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Ambulatory ECG

24h ECG monitoring

Intervention Type OTHER

Blood sample

The usual biological tests necessary for the management of the child and the addition of 1 tube of 2 ml

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

* Taking treatments that can alter the ANS (β-blockers, etc.) or inflammation (NSAIDs, corticosteroids)

* 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

* 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.)

* 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 1 month.
* Taking treatments that can alter the ANS (β-blockers, etc.) or inflammation (NSAIDs, corticosteroids)

Minimum Eligible Age

1 Day

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes