Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

Septic Shock Clinical Trial

— SAMIRA  

Official title:

Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041663
• Other study ID #: AOR 10106
• Status: Completed
• Phase: N/A
• Start date: March 5, 2012
• Est. completion date: July 11, 2018

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 11, 2018
• Est. primary completion date: July 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Meningococcal Infections
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock, Septic
• Toxemia

Intervention

Biological:
• BNP
Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5

Locations

Country	Name	City	State
France	AP-HP, Necker hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeated brain natriuretic peptide (BNP) blood level		Up to day 5
Secondary	Repeated cardiac echography		Up to day 5
Secondary	PRISM II gravity score		Up to day 5
Secondary	Organ failure PELOD score		Up to day 5
Secondary	Troponin rate		Up to day 5
Secondary	mortality and morbidity (aftereffects)		Day 28 and hospital discharge