NCT02041663

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2018

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

6.4 years

First QC Date

January 20, 2014

Last Update Submit

August 25, 2023

Conditions

Meningococcal InfectionsSeptic ShockSevere Sepsis

Keywords

brain natriuretic peptidecardiac functionmeningococcal infectionsseptic shocksevere sepsis

Outcome Measures

Primary Outcomes (1)

  • Repeated brain natriuretic peptide (BNP) blood level

    Up to day 5

Secondary Outcomes (5)

  • Repeated cardiac echography

    Up to day 5

  • PRISM II gravity score

    Up to day 5

  • Organ failure PELOD score

    Up to day 5

  • Troponin rate

    Up to day 5

  • mortality and morbidity (aftereffects)

    Day 28 and hospital discharge

Study Arms (1)

Population

EXPERIMENTAL

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

Biological: BNP

Interventions

BNPBIOLOGICAL

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

Population

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children
  • months to 18 years aged
  • without previous cardiac pathology
  • hospitalized in the participating pediatric intensive care units for serious sepsis with extensive purpura

You may not qualify if:

  • Heart malformative disorder with right-left shunt
  • Pre-existent known cardiac insufficiency whatever is the origin
  • Concomitant participation in another trial
  • Not membership in a national insurance scheme

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP, Necker hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Meningococcal InfectionsShock, SepticSepsis

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Jean Bergougnoux, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 22, 2014

Study Start

March 5, 2012

Primary Completion

July 11, 2018

Study Completion

July 11, 2018

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

FR(1)