SepsisDysREApedNCT05807555
Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children
An observational study of Sepsis and Autonomic Nervous System, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 1 day to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Autonomic Nervous System
- What is being tested?
- Ambulatory ECG and Blood sample
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children hospitalized in pediatric intensive care unit for severe sepsis Healthy children
Who may be able to join
- 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
- 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
Who cannot join
- 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)
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu de Saint-Etienne
Saint-Etienne, 42055
Hugues PATURAL, MD-PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis, Autonomic Nervous System
- Being tested
- Ambulatory ECG, Blood sample
- Keywords
- Dysautonomia
- Medical subject headings
- Sepsis, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory ECGOther
24h ECG monitoring
Blood sampleBiological
The usual biological tests necessary for the management of the child and the addition of 1 tube of 2 ml
| Study group | Role | What they receive |
|---|---|---|
| Infant with sepsis (Case) | Patient hospitalized in the pediatric intensive care unit (ICU) for severe sepsis Receives: 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 Receives: Other: Ambulatory ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Measured: Through discharge from the ICU, an average of 15 days
Plot (Poincaré plot)) evaluation
Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Measured: 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
Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Measured: Through discharge from the ICU, an average of 15 days
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
Measured: Through discharge from the ICU, an average of 15 days
Parasympathetic indices HF (High Frequency) evaluation
Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Measured: Through discharge from the ICU, an average of 15 days
Sympathetic indices (LF, LF/HF ratio) evaluation
Measured continuously in quiet sleep at night, by temporal, geometric, frequency, fractal and entropy analysis
Measured: Through discharge from the ICU, an average of 15 days
Evolution of biological markers of inflammation: CRP (C-reactive protein) (mg/L)
Collection of blood sampling for analysis
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Procalcitonin (ng/mL)
Collection of blood sampling for analysis
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Leukocytes (G/L)
Collection of blood sampling for analysis
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Ferritin (µg/L)s
Collection of blood sampling for analysis
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Fibrinogen (g/L)
Collection of blood sampling for analysis
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Platelets (G/L)
Collection of blood sampling for analysis
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Evolution of biological markers of inflammation : Triglycerides (g/L)
Collection of blood sampling for analysis
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Interferon alpha, interferon beta and interferon gamma.
Analysed by Luminex from blood sample (pg/mg)
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Tumor Necrosis Factor (TNF)
Analysed by Luminex from blood sample (pg/ml)
Measured: 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)
Analysed by Luminex from blood sample (pg/ml)
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Presence or absence of virus in blood
PCR (Polymerase chain reaction) multiplex
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Presence or absence of bacteria in blood
Blood cultures
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Presence or absence of bacteria in bone-marrow
Lumbar puncture
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Presence or absence of bacteria in urine
cytobacteriological examination of urine
Measured: Day : 1, at discharge from the ICU, an average of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start29 Mar 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HUGUES PATURAL, MD-PHD, Principal investigator, CHU DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807555
- Sponsor's protocol ID
- 22CH528
- Other IDs
- 2022-A02587-36
- Acronym
- DysREAped
- Status last verified
- May 2024
- First submitted
- 13 Feb 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evolution of Biomarkers of Dysautonomia and Inflammation During Sepsis in Children - An Observational Study
- ClinicalTrials.gov ID
- NCT05807555
- Acronym / sponsor ID
- DysREAped / 22CH528
- Conditions
- Sepsis, Autonomic Nervous System
- Keywords
- Dysautonomia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant with sepsis (Case) | – | Other: Ambulatory ECG, Biological: Blood samplePatient hospitalized in the pediatric intensive care unit (ICU) for severe sepsis |
| Healthy child of the same sex and age (Control) | – | Other: Ambulatory ECGHealthy children will be matched to cases by age and gender |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children hospitalized in pediatric intensive care unit for severe sepsis Healthy children
Key inclusion criteria (6 listed)
- 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
- Patient affiliated or entitled to a social security scheme
Key exclusion criteria (8 listed)
- 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)
- Parents or legal guardians who do not speak French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory ECG24h ECG monitoring | Other | Healthy child of the same sex and age (Control), Infant with sepsis (Case) |
| Blood sampleThe usual biological tests necessary for the management of the child and the addition of 1 tube of 2 ml | Biological | Infant with sepsis (Case) |
Primary outcome
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.
20 secondary outcomes
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
Plot (Poincaré plot)) evaluation
Time frame: 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
Parasympathetic indices RMSSD (Root mean square of successive RR interval differences) evaluation
Time frame: 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
Sympathetic indices (LF, LF/HF ratio) evaluation
Time frame: 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
Evolution of biological markers of inflammation : Procalcitonin (ng/mL)
Time frame: 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
Evolution of biological markers of inflammation : Ferritin (µg/L)s
Time frame: 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
Evolution of biological markers of inflammation : Platelets (G/L)
Time frame: 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
Interferon alpha, interferon beta and interferon gamma.
Time frame: 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
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
Presence or absence of virus in blood
Time frame: 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
Presence or absence of bacteria in bone-marrow
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HUGUES PATURAL, MD-PHD principal investigator
CHU DE SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Autonomic Nervous System, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HUGUES PATURAL, MD-PHD ((0)4 77 82 85 42 ext. +33, hugues.patural@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.