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Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis (SAMIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02041663
Recruitment Status : Unknown
Verified September 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : January 22, 2014
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Meningococcal Infections Septic Shock Severe Sepsis Biological: BNP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis
Study Start Date : February 2012
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Experimental: Population
Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5
Biological: BNP
Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5




Primary Outcome Measures :
  1. Repeated brain natriuretic peptide (BNP) blood level [ Time Frame: Up to day 5 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041663


Contacts
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Contact: Jean Bergounioux, MD +33 (0)1 44 49 42 18 jean.bergounioux@nck.aphp.fr

Locations
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France
AP-HP, Necker hospital Recruiting
Paris, France, 75015
Contact: Jean Bergougnoux, MD         
Principal Investigator: Jean Bergougnoux, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean Bergougnoux, MD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02041663    
Other Study ID Numbers: AOR 10106
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Keywords provided by Assistance Publique - Hôpitaux de Paris:
brain natriuretic peptide
cardiac function
meningococcal infections
septic shock
severe sepsis
Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Meningococcal Infections
Meningitis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Central Nervous System Diseases
Nervous System Diseases