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Completed

NCT Number: NCT00835913

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Grenoble

Grenoble, 38000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 48 hours post admission

Secondary outcomes

  1. plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: SNA&Sepsis

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 4, 2009
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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