Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children - An Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Kinetic of the HF(High Frequency) index (ms2/Hz) of heart rate variability
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Kinetic of the HF(High Frequency) index (ms2/Hz) of heart rate variability
Time Frame: 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 Outcomes
- 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)
- Global activity indices (SDNN (Standard deviation of the NN (R-R) intervals) evaluation(Through discharge from the ICU, an average of 15 days)
- Sympathetic indices (LF, LF/HF ratio) evaluation(Through discharge from the ICU, an average of 15 days)
- Evolution of biological markers of inflammation : Procalcitonin (ng/mL)(Day : 1, at discharge from the ICU, an average of 90 days)
- Parasympathetic indices RMSSD (Root mean square of successive RR interval differences) evaluation(Through discharge from the ICU, an average of 15 days)
- Evolution of biological markers of inflammation: CRP (C-reactive protein) (mg/L)(Day : 1, at discharge from the ICU, an average of 90 days)
- Evolution of biological markers of inflammation : Ferritin (µg/L)s(Day : 1, at discharge from the ICU, an average of 90 days)
- Evolution of biological markers of inflammation : Fibrinogen (g/L)(Day : 1, at discharge from the ICU, an average of 90 days)
- Plot (Poincaré plot)) evaluation(Through discharge from the ICU, an average of 15 days)
- Evolution of biological markers of inflammation : Leukocytes (G/L)(Day : 1, at discharge from the ICU, an average of 90 days)
- Interferon alpha, interferon beta and interferon gamma.(Day : 1, at discharge from the ICU, an average of 90 days)
- Presence or absence of bacteria in urine(Day : 1, at discharge from the ICU, an average of 90 days)
- Parasympathetic indices HF (High Frequency) evaluation(Through discharge from the ICU, an average of 15 days)
- Evolution of biological markers of inflammation : Triglycerides (g/L)(Day : 1, at discharge from the ICU, an average of 90 days)
- Tumor Necrosis Factor (TNF)(Day : 1, at discharge from the ICU, an average of 90 days)
- 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)
- Evolution of biological markers of inflammation : Platelets (G/L)(Day : 1, at discharge from the ICU, an average of 90 days)
- Presence or absence of bacteria in bone-marrow(Day : 1, at discharge from the ICU, an average of 90 days)
- Presence or absence of virus in blood(Day : 1, at discharge from the ICU, an average of 90 days)
- Presence or absence of bacteria in blood(Day : 1, at discharge from the ICU, an average of 90 days)