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

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

      • Grenoble, France, 38000
        • University Hospital Grenoble

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
48 hours post admission

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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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