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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00835913
First received: February 3, 2009
Last updated: July 8, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Phase
Septic Shock
Severe Sepsis
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission [ Time Frame: 48 hours post admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Peptid and protein sAmple


Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835913

Contacts
Contact: SCHWEBEL Carole, PH 04 76 76 55 05 Carole.Schwebel@chu-grenoble.fr
Contact: TIMSIT Jean francois, PU PH 04 76 76 87 79 jftimsit@chu-grenoble.fr

Locations
France
University Hospital Grenoble Recruiting
Grenoble, France, 38000
Contact: SCHWEBEL Carole, PH     04 76 76 55 05     Carole.Schwebel@chu-grenoble.fr    
Contact: TIMSIT Jean Francois, PU PH     04 76 76 87 79     jftimsit@chu-grenoble.fr    
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: SCHWEBEL Carole, PH Unit intensive care
  More Information

No publications provided

Responsible Party: Ms Carole SCHWEBEL, Service de réanimation médicale
ClinicalTrials.gov Identifier: NCT00835913     History of Changes
Other Study ID Numbers: 06PHR04, 2008-A00453-52
Study First Received: February 3, 2009
Last Updated: July 8, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Shock, Septic
 Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013