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

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ClinicalTrials.gov Identifier: NCT00835913
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

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
Septic Shock Severe Sepsis

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 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 : October 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources




Primary Outcome Measures :
  1. Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission [ Time Frame: 48 hours post admission ]

Secondary Outcome Measures :
  1. plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
Peptid and protein sAmple


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patient transfer in intensive care unit with sepsis chock or severe sepsis define as Bone criteria.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835913


Locations
France
University Hospital Grenoble
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: SCHWEBEL Carole, PH Unit intensive care

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00835913     History of Changes
Other Study ID Numbers: 06PHR04
2008-A00453-52
First Posted: February 4, 2009    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: July 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
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock