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CompletedNCT02041663SAMIRAUpdated Aug 28, 2023

Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

An interventional study of BNP in Meningococcal Infections, Septic Shock and Severe Sepsis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2023-08-28.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Mar 2012, registered Jan 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
6 Months to 18 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Meningococcal Infections
  • Septic Shock
  • Severe Sepsis

Keywords

  • brain natriuretic peptide
  • cardiac function
  • meningococcal infections
  • septic shock
  • severe sepsis
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 35 is below the median of 105 across 896 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 18 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Population

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

    Biological: BNP

Interventions

  • BiologicalBNP

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

06

What researchers measure

Primary outcomes

  1. Repeated brain natriuretic peptide (BNP) blood level

    Time frame: Up to day 5

Secondary outcomes

  1. Repeated cardiac echography

    Time frame: Up to day 5

  2. PRISM II gravity score

    Time frame: Up to day 5

  3. Organ failure PELOD score

    Time frame: Up to day 5

  4. Troponin rate

    Time frame: Up to day 5

  5. mortality and morbidity (aftereffects)

    Time frame: Day 28 and hospital discharge

07

Study locations

1 site
  • AP-HP, Necker hospital
    Paris, 75015, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02041663
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jan 22, 2014
Start date
Mar 5, 2012
Primary completion
Jul 11, 2018
Completion
Jul 11, 2018
Last update
Aug 28, 2023

Study contacts

Jean Bergougnoux, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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