NCT00835913

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 19, 2015

Status Verified

July 1, 2010

Enrollment Period

2.9 years

First QC Date

February 3, 2009

Last Update Submit

January 16, 2015

Conditions

Septic ShockSevere Sepsis

Keywords

Autonomic nervous systemSepsis shocksevere sepsissinusal changeMyocardiac fixingNTproBNPPatient in intensive care unit with sepsis shock or severeSepsis

Outcome Measures

Primary Outcomes (1)

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

    48 hours post admission

Secondary Outcomes (1)

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

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patient transfer in intensive care unit with sepsis chock or severe sepsis define as Bone criteria.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, 38000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peptid and protein sAmple

MeSH Terms

Conditions

Shock, SepticSepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • SCHWEBEL Carole, PH

    Unit intensive care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

October 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 19, 2015

Record last verified: 2010-07

Locations

FR(1)