Sepsis Clinical Trial
— DysREApedOfficial title:
Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children - An Observational Study
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 17 Years |
Eligibility | 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 (ß-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 (ß-blockers, etc.) or inflammation (NSAIDs, corticosteroids) |
Country | Name | City | State |
---|---|---|---|
France | Chu de Saint-Etienne | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Kinetic of the HF(High Frequency) index (ms2/Hz) of heart rate variability | 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. | Through discharge from the ICU, an average of 15 days | |
Secondary | Global activity indices (SDNN (Standard deviation of the NN (R-R) intervals) evaluation | Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis | Through discharge from the ICU, an average of 15 days | |
Secondary | Plot (Poincaré plot)) evaluation | Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis | Through discharge from the ICU, an average of 15 days | |
Secondary | Parasympathetic indices (pNN50 (Percentage of successive RR intervals that differ by more than 50 ms) evaluation | Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis | Through discharge from the ICU, an average of 15 days | |
Secondary | Parasympathetic indices RMSSD (Root mean square of successive RR interval differences) evaluation | Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis | Through discharge from the ICU, an average of 15 days | |
Secondary | Parasympathetic indices HF (High Frequency) evaluation | Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis | Through discharge from the ICU, an average of 15 days | |
Secondary | Sympathetic indices (LF, LF/HF ratio) evaluation | Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis | Through discharge from the ICU, an average of 15 days | |
Secondary | Evolution of biological markers of inflammation: CRP (C-reactive protein) (mg/L) | Collection of blood sampling for analysis | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Evolution of biological markers of inflammation : Procalcitonin (ng/mL) | Collection of blood sampling for analysis | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Evolution of biological markers of inflammation : Leukocytes (G/L) | Collection of blood sampling for analysis | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Evolution of biological markers of inflammation : Ferritin (µg/L)s | Collection of blood sampling for analysis | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Evolution of biological markers of inflammation : Fibrinogen (g/L) | Collection of blood sampling for analysis | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Evolution of biological markers of inflammation : Platelets (G/L) | Collection of blood sampling for analysis | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Evolution of biological markers of inflammation : Triglycerides (g/L) | Collection of blood sampling for analysis | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Interferon alpha, interferon beta and interferon gamma. | Analysed by Luminex from blood sample (pg/mg) | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Tumor Necrosis Factor (TNF) | Analysed by Luminex from blood sample (pg/ml) | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Interleukines (IL1, IL2, IL3; IL4, IL5, IL6, IL7, IL8, IL9, IL10, IL11, IL12, IL13) | Analysed by Luminex from blood sample (pg/ml) | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Presence or absence of virus in blood | PCR (Polymerase chain reaction) multiplex | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Presence or absence of bacteria in blood | Blood cultures | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Presence or absence of bacteria in bone-marrow | Lumbar puncture | Day : 1, at discharge from the ICU, an average of 90 days | |
Secondary | Presence or absence of bacteria in urine | cytobacteriological examination of urine | Day : 1, at discharge from the ICU, an average of 90 days |
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