Clinical trial NCT05807555: Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children
Official title: Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children - An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Autonomic Nervous System
Keywords: Dysautonomia
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children hospitalized in pediatric intensive care unit for severe sepsis

Healthy children

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.

Eligibility 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)

Primary outcomes:
measure: Kinetic of the HF(High Frequency) index (ms2/Hz) of heart rate variability
timeFrame: Through discharge from the ICU, an average of 15 days
Secondary outcomes:
measure: Global activity indices (SDNN (Standard deviation of the NN (R-R) intervals) evaluation
timeFrame: Through discharge from the ICU, an average of 15 days
measure: Plot (Poincaré plot)) evaluation
timeFrame: Through discharge from the ICU, an average of 15 days
measure: Parasympathetic indices (pNN50 (Percentage of successive RR intervals that differ by more than 50 ms) evaluation
timeFrame: Through discharge from the ICU, an average of 15 days
measure: Parasympathetic indices RMSSD (Root mean square of successive RR interval differences) evaluation
timeFrame: Through discharge from the ICU, an average of 15 days
measure: Parasympathetic indices HF (High Frequency) evaluation
timeFrame: Through discharge from the ICU, an average of 15 days
measure: Sympathetic indices (LF, LF/HF ratio) evaluation
timeFrame: Through discharge from the ICU, an average of 15 days
measure: Evolution of biological markers of inflammation: CRP (C-reactive protein) (mg/L)
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Evolution of biological markers of inflammation : Procalcitonin (ng/mL)
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Evolution of biological markers of inflammation : Leukocytes (G/L)
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Evolution of biological markers of inflammation : Ferritin (µg/L)s
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Evolution of biological markers of inflammation : Fibrinogen (g/L)
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Evolution of biological markers of inflammation : Platelets (G/L)
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Evolution of biological markers of inflammation : Triglycerides (g/L)
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Interferon alpha, interferon beta and interferon gamma.
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Tumor Necrosis Factor (TNF)
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Interleukines (IL1, IL2, IL3; IL4, IL5, IL6, IL7, IL8, IL9, IL10, IL11, IL12, IL13)
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Presence or absence of virus in blood
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Presence or absence of bacteria in blood
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Presence or absence of bacteria in bone-marrow
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
measure: Presence or absence of bacteria in urine
timeFrame: Day : 1, at discharge from the ICU, an average of 90 days
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu de Saint-Etienne
Study officials:
affiliation: CHU DE SAINT-ETIENNE
name: HUGUES PATURAL, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References: