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Clinical Trials/NCT00835913
NCT00835913CompletedNot Applicable

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

University Hospital, Grenoble1 site in 1 country13 target enrollmentStarted: October 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
13
Locations
1
Primary Endpoint
Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Patient under guardianship or trusteeship
  • pregnant or lactating women
  • 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

Outcomes

Primary Outcomes

Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission

Time Frame: 48 hours post admission

Secondary Outcomes

  • plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation(30 days)

Investigators

Sponsor
University Hospital, Grenoble
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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