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

Completed

• Conditions: Septic Shock; Severe Sepsis

• Registration Number: NCT00835913
• Lead Sponsor: University Hospital, Grenoble

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Status Verified: 2010-07
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation	30 days

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France