Septic cArdiac Deficiency and MenIngococcal seveRe Sepsis (SAMIRA)

August 25, 2023 updated by: Assistance Publique - Hôpitaux de Paris
Use of brain natriuretic peptide to evaluate the cardiac function in the course of meningococcal septic shock or severe sepsis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75015
        • AP-HP, Necker hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Repeated brain natriuretic peptide (BNP) blood level
Time Frame: Up to day 5
Up to day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Repeated cardiac echography
Time Frame: Up to day 5
Up to day 5
PRISM II gravity score
Time Frame: Up to day 5
Up to day 5
Organ failure PELOD score
Time Frame: Up to day 5
Up to day 5
Troponin rate
Time Frame: Up to day 5
Up to day 5
mortality and morbidity (aftereffects)
Time Frame: Day 28 and hospital discharge
Day 28 and hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean Bergougnoux, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2012

Primary Completion (Actual)

July 11, 2018

Study Completion (Actual)

July 11, 2018

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimated)

January 22, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOR 10106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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