Tracking changes in autonomic nervous system markers during sepsis in children
Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children - An Observational Study
This study is trying to see how the body's automatic responses change in children with severe sepsis in the ICU, looking at different infections and their effects on heart and blood markers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 1 Day to 17 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne) |
| Trial ID | NCT05807555 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor the evolution of sympathetic and parasympathetic markers of dysautonomia in children admitted to intensive care units for severe sepsis. It will analyze how these autonomic indices change based on the infection site and types of pathogens while correlating them with inflammation biomarkers and cytokines. The study involves ambulatory ECG and blood sample collection to gather data on the autonomic nervous system's response during severe inflammatory conditions.
Who should consider this trial
Good fit: Ideal candidates include children hospitalized in intensive care units who meet sepsis criteria.
Not a fit: Patients with chronic or acute conditions that affect autonomic balance or those recently under general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of dysautonomia in pediatric sepsis, potentially leading to improved treatment strategies.
How similar studies have performed: While the anti-inflammatory effects of the autonomic nervous system have been well studied, this specific approach to understanding its balance during severe inflammation in children is novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Saint-Etienne
- Chu de Saint-Etienne — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Hugues Patural, Md-Phd — Chu de Saint-Etienne
- Study coordinator: Hugues Patural, Md-Phd
- Email: hugues.patural@chu-st-etienne.fr
- Phone: (0)4 77 82 85 42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.