Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children
- Conditions
- SepsisAutonomic Nervous System
- Interventions
- Other: Ambulatory ECGBiological: Blood sample
- Registration Number
- NCT05807555
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy child of the same sex and age (Control) Ambulatory ECG Healthy children will be matched to cases by age and gender Infant with sepsis (Case) Ambulatory ECG Patient hospitalized in the pediatric intensive care unit (ICU) for severe sepsis Infant with sepsis (Case) Blood sample Patient hospitalized in the pediatric intensive care unit (ICU) for severe sepsis
- Primary Outcome Measures
Name Time Method Kinetic of the HF(High Frequency) index (ms2/Hz) of heart rate variability Through discharge from the ICU, an average of 15 days Measure of the HF index of heart rate continuously at the patient's bed, during a quiet sleep phase at night, day by day for the entire duration of hospitalization in the ICU.
- Secondary Outcome Measures
Name Time Method Parasympathetic indices (pNN50 (Percentage of successive RR intervals that differ by more than 50 ms) evaluation Through discharge from the ICU, an average of 15 days Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Global activity indices (SDNN (Standard deviation of the NN (R-R) intervals) evaluation Through discharge from the ICU, an average of 15 days Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Sympathetic indices (LF, LF/HF ratio) evaluation Through discharge from the ICU, an average of 15 days Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Evolution of biological markers of inflammation : Procalcitonin (ng/mL) Day : 1, at discharge from the ICU, an average of 90 days Collection of blood sampling for analysis
Parasympathetic indices RMSSD (Root mean square of successive RR interval differences) evaluation Through discharge from the ICU, an average of 15 days Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Evolution of biological markers of inflammation: CRP (C-reactive protein) (mg/L) Day : 1, at discharge from the ICU, an average of 90 days Collection of blood sampling for analysis
Evolution of biological markers of inflammation : Ferritin (µg/L)s Day : 1, at discharge from the ICU, an average of 90 days Collection of blood sampling for analysis
Evolution of biological markers of inflammation : Fibrinogen (g/L) Day : 1, at discharge from the ICU, an average of 90 days Collection of blood sampling for analysis
Evolution of biological markers of inflammation : Leukocytes (G/L) Day : 1, at discharge from the ICU, an average of 90 days Collection of blood sampling for analysis
Interferon alpha, interferon beta and interferon gamma. Day : 1, at discharge from the ICU, an average of 90 days Analysed by Luminex from blood sample (pg/mg)
Presence or absence of bacteria in urine Day : 1, at discharge from the ICU, an average of 90 days cytobacteriological examination of urine
Plot (Poincaré plot)) evaluation Through discharge from the ICU, an average of 15 days Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Parasympathetic indices HF (High Frequency) evaluation Through discharge from the ICU, an average of 15 days Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Evolution of biological markers of inflammation : Triglycerides (g/L) Day : 1, at discharge from the ICU, an average of 90 days Collection of blood sampling for analysis
Tumor Necrosis Factor (TNF) Day : 1, at discharge from the ICU, an average of 90 days Analysed by Luminex from blood sample (pg/ml)
Interleukines (IL1, IL2, IL3; IL4, IL5, IL6, IL7, IL8, IL9, IL10, IL11, IL12, IL13) Day : 1, at discharge from the ICU, an average of 90 days Analysed by Luminex from blood sample (pg/ml)
Evolution of biological markers of inflammation : Platelets (G/L) Day : 1, at discharge from the ICU, an average of 90 days Collection of blood sampling for analysis
Presence or absence of bacteria in bone-marrow Day : 1, at discharge from the ICU, an average of 90 days Lumbar puncture
Presence or absence of virus in blood Day : 1, at discharge from the ICU, an average of 90 days PCR (Polymerase chain reaction) multiplex
Presence or absence of bacteria in blood Day : 1, at discharge from the ICU, an average of 90 days Blood cultures
Trial Locations
- Locations (1)
Chu de Saint-Etienne
🇫🇷Saint-Étienne, France