Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children

NCT05807555 | Recruiting

• 2 other identifiers: 22CH5282022-A02587-36
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Autonomic Nervous System

Keywords

Dysautonomia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Global activity indices (SDNN (Standard deviation of the NN (R-R) intervals) evaluation

  Through discharge from the ICU, an average of 15 days

• Plot (Poincaré plot)) evaluation

  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

  Through discharge from the ICU, an average of 15 days

• Parasympathetic indices RMSSD (Root mean square of successive RR interval differences) evaluation

  Through discharge from the ICU, an average of 15 days

• Parasympathetic indices HF (High Frequency) evaluation

  Through discharge from the ICU, an average of 15 days

Study Arms (2)

Infant with sepsis (Case)

Patient hospitalized in the pediatric intensive care unit (ICU) for severe sepsis

Other: Ambulatory ECG; Biological: Blood sample

Healthy child of the same sex and age (Control)

Healthy children will be matched to cases by age and gender

Other: Ambulatory ECG

Interventions

Ambulatory ECG OTHER

24h ECG monitoring

Healthy child of the same sex and age (Control); Infant with sepsis (Case)

Blood sample BIOLOGICAL

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

Infant with sepsis (Case)

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children hospitalized in pediatric intensive care unit for severe sepsis Healthy children

You may qualify if:

• 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

You may not qualify if:

• 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.)
• Taking treatments that can alter the ANS (β-blockers, etc.) or inflammation (NSAIDs, corticosteroids)
• 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
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu de Saint-Etienne

Saint-Etienne, 42055, France

RECRUITING

MeSH Terms

Conditions

Sepsis; Autonomic Nervous System Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• HUGUES PATURAL, MD-PHD

  CHU DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HUGUES PATURAL, MD-PHD

CONTACT

(0)4 77 82 85 42; hugues.patural@chu-st-etienne.fr

MARINE DUBOIS, Resident

CONTACT

0477828454; marine.dubois163@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: April 11, 2023
• Study Start: March 29, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

FR (1)