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
Recruitment status was Recruiting
Sponsor:
University Hospital, Grenoble
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00835913
First received: February 3, 2009
Last updated: July 8, 2010
Last verified: July 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 3, 2009 | ||||||||
| Last Updated Date | July 8, 2010 | ||||||||
| Start Date ICMJE | October 2008 | ||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00835913 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
plasmatic measure of NT-ProBNP and catecolamine at admission, day 2 and last day of hospitalisation [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Autonomic Nervous System Alteration Induce by Sepsis: Assessment and Prognosis Impact | ||||||||
| Official Title ICMJE | Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Peptid and protein sAmple |
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| Sampling Method | Probability Sample | ||||||||
| Study Population | All patient transfer in intensive care unit with sepsis chock or severe sepsis define as Bone criteria. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Estimated Completion Date | September 2011 | ||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00835913 | ||||||||
| Other Study ID Numbers ICMJE | 06PHR04, 2008-A00453-52 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Ms Carole SCHWEBEL, Service de réanimation médicale | ||||||||
| Study Sponsor ICMJE | University Hospital, Grenoble | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Grenoble | ||||||||
| Verification Date | July 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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