Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05807555
Acronym
DysREAped
Enrollment
60
Registered
2023-04-11
Start date
2023-03-29
Completion date
2025-01-01
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Nervous System, Sepsis

Keywords

Dysautonomia

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.

Interventions

24h ECG monitoring

BIOLOGICALBlood sample

The usual biological tests necessary for the management of the child and the addition of 1 tube of 2 ml

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Kinetic of the HF(High Frequency) index (ms2/Hz) of heart rate variabilityThrough discharge from the ICU, an average of 15 daysMeasure 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

MeasureTime frameDescription
Plot (Poincaré plot)) evaluationThrough discharge from the ICU, an average of 15 daysMeasured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Parasympathetic indices (pNN50 (Percentage of successive RR intervals that differ by more than 50 ms) evaluationThrough discharge from the ICU, an average of 15 daysMeasured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Parasympathetic indices RMSSD (Root mean square of successive RR interval differences) evaluationThrough discharge from the ICU, an average of 15 daysMeasured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Parasympathetic indices HF (High Frequency) evaluationThrough discharge from the ICU, an average of 15 daysMeasured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Sympathetic indices (LF, LF/HF ratio) evaluationThrough discharge from the ICU, an average of 15 daysMeasured 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 daysCollection of blood sampling for analysis
Evolution of biological markers of inflammation : Procalcitonin (ng/mL)Day : 1, at discharge from the ICU, an average of 90 daysCollection 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 daysCollection of blood sampling for analysis
Evolution of biological markers of inflammation : Ferritin (µg/L)sDay : 1, at discharge from the ICU, an average of 90 daysCollection of blood sampling for analysis
Global activity indices (SDNN (Standard deviation of the NN (R-R) intervals) evaluationThrough discharge from the ICU, an average of 15 daysMeasured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Evolution of biological markers of inflammation : Platelets (G/L)Day : 1, at discharge from the ICU, an average of 90 daysCollection of blood sampling for analysis
Evolution of biological markers of inflammation : Triglycerides (g/L)Day : 1, at discharge from the ICU, an average of 90 daysCollection of blood sampling for analysis
Interferon alpha, interferon beta and interferon gamma.Day : 1, at discharge from the ICU, an average of 90 daysAnalysed by Luminex from blood sample (pg/mg)
Tumor Necrosis Factor (TNF)Day : 1, at discharge from the ICU, an average of 90 daysAnalysed 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 daysAnalysed by Luminex from blood sample (pg/ml)
Presence or absence of virus in bloodDay : 1, at discharge from the ICU, an average of 90 daysPCR (Polymerase chain reaction) multiplex
Presence or absence of bacteria in bloodDay : 1, at discharge from the ICU, an average of 90 daysBlood cultures
Presence or absence of bacteria in bone-marrowDay : 1, at discharge from the ICU, an average of 90 daysLumbar puncture
Presence or absence of bacteria in urineDay : 1, at discharge from the ICU, an average of 90 dayscytobacteriological examination of urine
Evolution of biological markers of inflammation : Fibrinogen (g/L)Day : 1, at discharge from the ICU, an average of 90 daysCollection of blood sampling for analysis

Countries

France

Contacts

Primary ContactHUGUES PATURAL, MD-PHD
hugues.patural@chu-st-etienne.fr(0)4 77 82 85 42
Backup ContactMARINE DUBOIS, Resident
marine.dubois163@hotmail.com0477828454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026