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Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis (SAMIRA)

Primary Purpose

Meningococcal Infections, Septic Shock, Severe Sepsis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

BNP

About this trial

This is an interventional diagnostic trial for Meningococcal Infections focused on measuring brain natriuretic peptide, cardiac function, meningococcal infections, septic shock, severe sepsis

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

AP-HP, Necker hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Population

Arm Description

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

Outcomes

Primary Outcome Measures

Repeated brain natriuretic peptide (BNP) blood level

Secondary Outcome Measures

Repeated cardiac echography

PRISM II gravity score

Organ failure PELOD score

Troponin rate

mortality and morbidity (aftereffects)

Full Information

NCT ID

NCT02041663

First Posted

January 20, 2014

Last Updated

August 25, 2023

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT02041663

Brief Title

Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

Acronym

SAMIRA

Official Title

Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

March 5, 2012 (Actual)

Primary Completion Date

July 11, 2018 (Actual)

Study Completion Date

July 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningococcal Infections, Septic Shock, Severe Sepsis

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Population

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

BNP

Intervention Description

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

Primary Outcome Measure Information:

Title

Repeated brain natriuretic peptide (BNP) blood level

Time Frame

Up to day 5

Secondary Outcome Measure Information:

Title

Repeated cardiac echography

Time Frame

Up to day 5

Title

PRISM II gravity score

Time Frame

Up to day 5

Title

Organ failure PELOD score

Time Frame

Up to day 5

Title

Troponin rate

Time Frame

Up to day 5

Title

mortality and morbidity (aftereffects)

Time Frame

Day 28 and hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Bergougnoux, MD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

AP-HP, Necker hospital

City

Paris

ZIP/Postal Code

75015

Country

France

12. IPD Sharing Statement

Learn more about this trial

Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis

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