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Completed

NCT Number: NCT02041663

Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

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

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Key information

Conditions

Meningococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Inflammation Neisseriaceae Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Severe Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP, Necker hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BNP

Biological

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

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: SAMIRA

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jan 22, 2014
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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