NCT05807555

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

Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children - An Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 1 Day – 17 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Sepsis
• Autonomic Nervous System

Interventions

Type	Name	Description
OTHER	Ambulatory ECG	24h ECG monitoring
BIOLOGICAL	Blood sample	The usual biological tests necessary for the management of the child and the addition of 1 tube of 2 ml

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2023-04-11
• Last updated: 2024-05-03

Locations

1 site across 1 country: France