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SIRS and Bacterial Sepsis Discrimination by Biomarkers in ICU (Captain)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01378169
Recruitment Status : Completed
First Posted : June 22, 2011
Last Update Posted : October 17, 2017
Institut Pasteur
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

Aim of the study : The primary aim of the investigators study is to highlight the presence of biomarkers (biological indicators of the presence of inflammation or infection) of infectious processes during the systemic inflammatory response (SIRS) allowing, first to discriminate non-infectious inflammation from infectious processes and secondary to determine the microbial pathogen responsive of the infection. For this purpose the investigators will conduct a combinatorial approach of several blood markers including usual markers of inflammation and other blood and cells markers. Expression of small pieces of RNA (miRNA) known to inhibit determined gene expression, will also be analysed in monocytes (a specific group of white blood cells involved in the fist line of defences against microbes.

Study design : For this purpose the investigators will include 300 patients admitted to the intensive care unit with suspicion of infection. Serial blood sample will be take for biological parameters analysis. Efficiency of each single parameters and of different combinations of different markers to determine the presence or absence of infection responsive of clinical inflammation will be studied.

Condition or disease
SIRS Sepsis Severe Sepsis Septic Shock

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection and Diagnostic Performance of Bio-markers During Bacterial Sepsis: Multicentre Cohort Study in Intensive Care
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : January 1, 2013
Actual Study Completion Date : June 1, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

SIRS patients
Every patient, without exclusion criteria, presenting with SIRS during an hospitalization in ICU.

Primary Outcome Measures :
  1. Combination of biomarkers in sepsis [ Time Frame: 3 days ( from D0 to D2) ]

    The primary endpoint is to determine the ability of each individual parameter and of the different combination to discriminate between sepsis and noninfectious inflammation.

    Each biomarker will be isolatelly studied to determine existence of a cut-off value allowing discrimination between SIRS and sepsis.

    Each positive biomarker (biomarker for which such a cut-off can be determined), will be include in a second study involving all or part of the positive biomarkers to determine the possibility of increasing AUC for discrimination of SIRS and sepsis patients

Secondary Outcome Measures :
  1. Pathogen in human fluids (Blood, BAL, CSF, Urin) [ Time Frame: D0 ]
    A partnership with Biomerieux laboratory was estabished to allow microbial detection at D0 by a new system of microbial DNA amplification, which is at the moment under development

  2. mRNA expression during inflammatory process in white blood cells [ Time Frame: D0 to D3 ]
    Study of modification of mRNA expression between SIRS and sepsis during inflammatory process in white blood cells. Study of the expression of whole mRNA in whole blood and of its modification during the 3 fist days of SIRS to determine a potential specific profil during infectious processes

Biospecimen Retention:   Samples Without DNA
blood, urin, CSF, BAL

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients whatever was their admission indication presenting a SIRS with or without sepsis.

Inclusion Criteria:

  • Age> = 18 years
  • Patient hospitalized in ICU with a diagnosis of SIRS:
  • Temperatures above 38 ° C or below 36 ° C

At least one other criterion from:

  • Heart rate> 90 bpm
  • Respiratory rate above 20 breaths / min or PaCO2 <32 mmHg
  • Leukocytosis greater than or less than 4000/mm3 12000/m3

    • Patient admitted in intensive care for less than 12 hours
    • Patient does not preclude its participation in the study.

Exclusion Criteria:

  • Decision to limit treatment before potential inclusion in the study
  • No affiliation to a social security scheme (beneficiary or assignee)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01378169

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Groupe hospitalier Paris Saint Joseph
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Institut Pasteur
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: François J Philippart, MD; PhD Groupe Hospitalier Paris Saint Joseph

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Responsible Party: Groupe Hospitalier Paris Saint Joseph Identifier: NCT01378169     History of Changes
Other Study ID Numbers: AOM09143
N° 2010-A00908-31 ( Other Identifier: AFSSAPS )
First Posted: June 22, 2011    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: March 2017

Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Severe Sepsis
Septic Shock
Inflammatory processes
HLA type II
TLR expression
mRNA expression in whole blood
Bacterial DNA detection
Prognosis factors

Additional relevant MeSH terms:
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Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes