Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children (DysREAped)

May 2, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France, 42055
        • Recruiting
        • CHU DE SAINT-ETIENNE
        • Principal Investigator:
          • Hugues PATURAL, MD-PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children hospitalized in pediatric intensive care unit for severe sepsis

Healthy children

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infant with sepsis (Case)
Patient hospitalized in the pediatric intensive care unit (ICU) for severe sepsis
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
Healthy child of the same sex and age (Control)
Healthy children will be matched to cases by age and gender
Other: Ambulatory ECG
24h ECG monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through discharge from the ICU, an average of 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global activity indices (SDNN (Standard deviation of the NN (R-R) intervals) evaluation
Time Frame: Through discharge from the ICU, an average of 15 days
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
Plot (Poincaré plot)) evaluation
Time Frame: Through discharge from the ICU, an average of 15 days
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
Parasympathetic indices (pNN50 (Percentage of successive RR intervals that differ by more than 50 ms) evaluation
Time Frame: Through discharge from the ICU, an average of 15 days
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
Parasympathetic indices RMSSD (Root mean square of successive RR interval differences) evaluation
Time Frame: Through discharge from the ICU, an average of 15 days
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
Parasympathetic indices HF (High Frequency) evaluation
Time Frame: Through discharge from the ICU, an average of 15 days
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
Sympathetic indices (LF, LF/HF ratio) evaluation
Time Frame: Through discharge from the ICU, an average of 15 days
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
Evolution of biological markers of inflammation: CRP (C-reactive protein) (mg/L)
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Collection of blood sampling for analysis
Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Procalcitonin (ng/mL)
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Collection of blood sampling for analysis
Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Leukocytes (G/L)
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Collection of blood sampling for analysis
Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Ferritin (µg/L)s
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Collection of blood sampling for analysis
Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Fibrinogen (g/L)
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Collection of blood sampling for analysis
Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Platelets (G/L)
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Collection of blood sampling for analysis
Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Triglycerides (g/L)
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Collection of blood sampling for analysis
Day : 1, at discharge from the ICU, an average of 90 days
Interferon alpha, interferon beta and interferon gamma.
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Analysed by Luminex from blood sample (pg/mg)
Day : 1, at discharge from the ICU, an average of 90 days
Tumor Necrosis Factor (TNF)
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Analysed by Luminex from blood sample (pg/ml)
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)
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Analysed by Luminex from blood sample (pg/ml)
Day : 1, at discharge from the ICU, an average of 90 days
Presence or absence of virus in blood
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
PCR (Polymerase chain reaction) multiplex
Day : 1, at discharge from the ICU, an average of 90 days
Presence or absence of bacteria in blood
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Blood cultures
Day : 1, at discharge from the ICU, an average of 90 days
Presence or absence of bacteria in bone-marrow
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
Lumbar puncture
Day : 1, at discharge from the ICU, an average of 90 days
Presence or absence of bacteria in urine
Time Frame: Day : 1, at discharge from the ICU, an average of 90 days
cytobacteriological examination of urine
Day : 1, at discharge from the ICU, an average of 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: HUGUES PATURAL, MD-PhD, CHU DE SAINT-ETIENNE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2023

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

April 11, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22CH528
  • 2022-A02587-36 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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