Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

Not Applicable

Completed

• Conditions: Meningococcal Infections; Severe Sepsis; Septic Shock
• Interventions: Biological: BNP

• Registration Number: NCT02041663
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-03-05
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-22
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-25
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Population	BNP	Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5

Primary Outcome Measures

Name	Time	Method
Repeated brain natriuretic peptide (BNP) blood level	Up to day 5

Secondary Outcome Measures

Name	Time	Method
Repeated cardiac echography	Up to day 5
PRISM II gravity score	Up to day 5
Organ failure PELOD score	Up to day 5
mortality and morbidity (aftereffects)	Day 28 and hospital discharge
Troponin rate	Up to day 5

Trial Locations

Locations (1)

AP-HP, Necker hospital; 🇫🇷 Paris, France