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SNA&Sepsis: Autonomic Nervous System Alteration Induce by Sepsis: Assessment and Prognosis Impact

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Completed
CT.gov ID
NCT00835913
Collaborator
(none)
13
Enrollment
1
Location
35
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Severe sepsis and septic shock are causes of admission in intensive care units.Modification of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to intensive care units.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Our principal aim is to characterize modulation of cardiac sympathic nervous system in sepsis through the study of sinusal change and myocardiac fixing of MIBG.

    The second aim is 1)to assess links between alteration of cardiac sympathic nervous system and NT-PRoBNP variations in sepsis and 2)To know prognostic impact in sympathic nervous system compare to NTproBNP.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    13 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact
    Study Start Date :
    Oct 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2011
    Actual Study Completion Date :
    Sep 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission [48 hours post admission]

    Secondary Outcome Measures

    1. plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patient over 18 years admitted in intensive care unit and having severe sepsis criteria or septic shock documented or suspected define as Bone Criteria

    • hemodynamically stable situation

    • sinusal rhythm

    • Patient for social security

    Exclusion Criteria:

    • Minors

    • Patient under guardianship or trusteeship

    • pregnant or lactating women

    • diabetic

    • cardiomyopathy known and/or treated or detect in admission

    • electro-systolic process permanent or transitory

    • neurological history or degenerative pathology

    • chronic respiratory insufficiency

    • Chronic renal insufficiency

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Grenoble Grenoble France 38000

    Sponsors and Collaborators

    • University Hospital, Grenoble

    Investigators

    • Principal Investigator: SCHWEBEL Carole, PH, Unit intensive care

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Grenoble
    ClinicalTrials.gov Identifier:
    NCT00835913
    Other Study ID Numbers:
    • 06PHR04
    • 2008-A00453-52
    First Posted:
    Feb 4, 2009
    Last Update Posted:
    Jan 19, 2015
    Last Verified:
    Jul 1, 2010
    Keywords provided by University Hospital, Grenoble
    Autonomic nervous system
    Sepsis shock
    severe sepsis
    sinusal change
    Myocardiac fixing
    NTproBNP
    Patient in intensive care unit with sepsis shock or severe
    Sepsis
    Additional relevant MeSH terms:
    Sepsis
    Toxemia

    Study Results

    No Results Posted as of Jan 19, 2015