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Search / Trial NCT05807555

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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT ETIENNE · Mar 29, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Dysautonomia

ClinConnect Summary

This clinical trial is looking at how the body's nervous system and inflammation interact during sepsis, a serious condition that can happen when the body responds to an infection. Researchers want to understand how inflammation affects the autonomic nervous system (ANS), which controls essential functions like heart rate and the body's response to inflammation. By studying children who are hospitalized with sepsis, the trial aims to identify how changes in the nervous system can influence recovery and treatment outcomes.

To be eligible for the study, children must be hospitalized in a pediatric intensive care unit and meet specific criteria for sepsis. Their parents or guardians need to provide consent and should speak French. Children with certain health issues or recent surgeries that could affect the results won’t be included. Participants can expect to undergo assessments and monitoring that will help researchers gather important data about their health during this critical time. This study is currently recruiting participants, and it aims to improve our understanding of sepsis in children, which could lead to better treatments in the future.

Gender

ALL

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)

About Centre Hospitalier Universitaire De Saint Etienne

The Centre Hospitalier Universitaire (CHU) de Saint-Étienne is a leading academic medical center in France, dedicated to advancing healthcare through innovative clinical research and high-quality patient care. With a robust infrastructure that supports a wide range of medical specialties, CHU de Saint-Étienne fosters collaboration between healthcare professionals, researchers, and academic institutions. The center is committed to conducting rigorous clinical trials that adhere to ethical standards and regulatory requirements, aiming to improve treatment outcomes and enhance the overall health of the community. Through its dedication to scientific excellence and patient-centered care, CHU de Saint-Étienne plays a pivotal role in the advancement of medical knowledge and the development of new therapeutic interventions.

Locations

Saint étienne, , France

Patients applied

0 patients applied

Trial Officials

HUGUES PATURAL, MD-PHD

Principal Investigator

CHU DE SAINT-ETIENNE

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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