- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00835913
Autonomic Nervous System Alteration Induce by Sepsis: Assessment and Prognosis Impact (SNA&Sepsis)
January 16, 2015 updated by: University Hospital, Grenoble
Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
13
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Grenoble, France, 38000
- University Hospital Grenoble
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All patient transfer in intensive care unit with sepsis chock or severe sepsis define as Bone criteria.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission
Time Frame: 48 hours post admission
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48 hours post admission
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation
Time Frame: 30 days
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: SCHWEBEL Carole, PH, Unit intensive care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
February 3, 2009
First Submitted That Met QC Criteria
February 3, 2009
First Posted (Estimate)
February 4, 2009
Study Record Updates
Last Update Posted (Estimate)
January 19, 2015
Last Update Submitted That Met QC Criteria
January 16, 2015
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06PHR04
- 2008-A00453-52
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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