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NCT00835913 Clinical Trial

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

Septic Shock Clinical Trial

— SNA&Sepsis  

Official title:
Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00835913
Other study ID # 06PHR04
Secondary ID 2008-A00453-52
Status Completed
Phase Phase 4
First received February 3, 2009
Last updated January 16, 2015
Start date October 2008
Est. completion date September 2011

Study information
Verified date July 2010
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 13
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France University Hospital Grenoble Grenoble

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission 48 hours post admission No
Secondary plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation 30 days No
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