Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children (DysREAped)

Centre Hospitalier Universitaire de Saint Etienne

Status

Enrolling

Conditions

Autonomic Nervous System

Sepsis

Treatments

Biological: Blood sample

Other: Ambulatory ECG

Study type

Observational

Funder types

Other

Identifiers

NCT05807555

2022-A02587-36 (Other Identifier)

22CH528

Details and patient eligibility

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

1 day to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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 signed the consent form

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