Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

Study Overview
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Brief Summary
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Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.

Detailed Description
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OBJECTIVES: determining sensibility and specificity of BNP blood level to detect myocardial dysfunction in septic shock or severe sepsis due to Neisseria meningitidis in children. METHODS: Prospective multicentric clinical trial including 7 French pediatric intensive care units. Serial cardiac ultra sounds and blood sampling will be done for patients hospitalized for purpura fulminans beginning at the time of admission in pediatric intensive care. Any child from 6 months to 18 years without preexisting cardiac disease and presenting with purpura fulminans will be enrolled after obtaining consent of both parents. From adult's studies on septic shock and BNP, a total number of 30 patients was calculated to be necessary to prove the interest of BNP in this indication.

Official Title
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Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

Conditions
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Meningococcal Infections, Septic Shock, Severe Sepsis

Intervention / Treatment
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* Biological: BNP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children 6 months to 18 years aged without previous cardiac pathology hospitalized in the participating pediatric intensive care units for serious sepsis with extensive purpura Exclusion Criteria: Heart malformative disorder with right-left shunt Pre-existent known cardiac insufficiency whatever is the origin Concomitant participation in another trial Patient in period of exclusion from another trial Not membership in a national insurance scheme

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Population<br>Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5 | Biological: BNP<br>* Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeated brain natriuretic peptide (BNP) blood level |  | Up to day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeated cardiac echography |  | Up to day 5 | 
| PRISM II gravity score |  | Up to day 5 | 
| Organ failure PELOD score |  | Up to day 5 | 
| Troponin rate |  | Up to day 5 | 
| mortality and morbidity (aftereffects) |  | Day 28 and hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain natriuretic peptide, cardiac function, meningococcal infections, septic shock, severe sepsis