BIOLOGICAL
BNP
Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5
Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis
Status
Completed
Phase
Not applicable
Enrollment
35
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.
Full detailed description
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jan 22, 2014
Study start
Mar 5, 2012
Primary completion
Jul 11, 2018
Study completion
Jul 11, 2018
Results posted
Not reported
Registry updated
Aug 28, 2023
Outcomes
What the study measures.
Primary outcomes
Repeated brain natriuretic peptide (BNP) blood level
Time frame · Up to day 5
Secondary outcomes
Repeated cardiac echography
Time frame · Up to day 5
PRISM II gravity score
Time frame · Up to day 5
Organ failure PELOD score
Time frame · Up to day 5
Troponin rate
Time frame · Up to day 5
mortality and morbidity (aftereffects)
Time frame · Day 28 and hospital discharge
Eligibility
Who can take part.
- Minimum age
- 6 Months
- Maximum age
- 18 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
AP-HP, Necker hospital
Paris, France
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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