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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05807555
Other study ID # 22CH528
Secondary ID 2022-A02587-36
Status Recruiting
Phase
First received
Last updated
Start date March 29, 2023
Est. completion date January 1, 2025

Study information

Verified date May 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact HUGUES PATURAL, MD-PHD
Phone (0)4 77 82 85 42
Email hugues.patural@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Ambulatory ECG
24h ECG monitoring
Biological:
Blood sample
The usual biological tests necessary for the management of the child and the addition of 1 tube of 2 ml

Locations

Country Name City State
France Chu de Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

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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