Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02041663

Acronym

SAMIRA

Enrollment

Registered

2014-01-22

Start date

2012-03-05

Completion date

2018-07-11

Last updated

2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Infections, Septic Shock, Severe Sepsis

Keywords

brain natriuretic peptide, cardiac function, meningococcal infections, septic shock, severe sepsis

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.

Interventions

BIOLOGICALBNP

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Repeated brain natriuretic peptide (BNP) blood level	Up to day 5

Secondary

Measure	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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026