Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis (SAMIRA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Meningococcal Infections; Severe Sepsis; Septic Shock

Treatments: Biological: BNP

Study type: Interventional

Funder types: Other

Identifiers

NCT02041663

AOR 10106

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Population

Experimental group

Description:

Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5

Treatment:

Biological: BNP