NCT01378169

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 17, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

May 9, 2011

Last Update Submit

October 15, 2017

Conditions

SIRSSepsisSevere SepsisSeptic Shock

Keywords

SIRSSepsisSevere SepsisSeptic ShockInflammatory processesCytokinesHLA-DRHLA type IIChemokinesTLR expressionmRNA expression in whole bloodBacterial DNA detectionPrognosis factorsInfectionDiagnosis

Outcome Measures

Primary Outcomes (1)

  • Combination of biomarkers in sepsis

    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

    3 days ( from D0 to D2)

Secondary Outcomes (2)

  • Pathogen in human fluids (Blood, BAL, CSF, Urin)

    D0

  • mRNA expression during inflammatory process in white blood cells

    D0 to D3

Study Arms (1)

SIRS patients

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

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients whatever was their admission indication presenting a SIRS with or without sepsis.

You may qualify if:

  • 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.

You may not qualify if:

  • No affiliation to a social security scheme (beneficiary or assignee)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe hospitalier Paris Saint Joseph

Paris, 75014, France

Location

Related Publications (8)

  • Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet. 2005 Jan 1-7;365(9453):63-78. doi: 10.1016/S0140-6736(04)17667-8.

    PMID: 15639681BACKGROUND

  • Gibot S, Cravoisy A, Levy B, Bene MC, Faure G, Bollaert PE. Soluble triggering receptor expressed on myeloid cells and the diagnosis of pneumonia. N Engl J Med. 2004 Jan 29;350(5):451-8. doi: 10.1056/NEJMoa031544.

    PMID: 14749453BACKGROUND

  • Adib-Conquy M, Monchi M, Goulenok C, Laurent I, Thuong M, Cavaillon JM, Adrie C. Increased plasma levels of soluble triggering receptor expressed on myeloid cells 1 and procalcitonin after cardiac surgery and cardiac arrest without infection. Shock. 2007 Oct;28(4):406-10. doi: 10.1097/shk.0b013e3180488154.

    PMID: 17558349BACKGROUND

  • Cavaillon JM, Adib-Conquy M, Fitting C, Adrie C, Payen D. Cytokine cascade in sepsis. Scand J Infect Dis. 2003;35(9):535-44. doi: 10.1080/00365540310015935.

    PMID: 14620132BACKGROUND

  • Adrie C, Adib-Conquy M, Laurent I, Monchi M, Vinsonneau C, Fitting C, Fraisse F, Dinh-Xuan AT, Carli P, Spaulding C, Dhainaut JF, Cavaillon JM. Successful cardiopulmonary resuscitation after cardiac arrest as a "sepsis-like" syndrome. Circulation. 2002 Jul 30;106(5):562-8. doi: 10.1161/01.cir.0000023891.80661.ad.

    PMID: 12147537BACKGROUND

  • Monneret G, Lepape A, Voirin N, Bohe J, Venet F, Debard AL, Thizy H, Bienvenu J, Gueyffier F, Vanhems P. Persisting low monocyte human leukocyte antigen-DR expression predicts mortality in septic shock. Intensive Care Med. 2006 Aug;32(8):1175-83. doi: 10.1007/s00134-006-0204-8. Epub 2006 Jun 2.

    PMID: 16741700BACKGROUND

  • Munoz C, Carlet J, Fitting C, Misset B, Bleriot JP, Cavaillon JM. Dysregulation of in vitro cytokine production by monocytes during sepsis. J Clin Invest. 1991 Nov;88(5):1747-54. doi: 10.1172/JCI115493.

    PMID: 1939659BACKGROUND

  • Misset B, Philippart F, Fitting C, Bedos JP, Diehl JL, Hamzaoui O, Annane D, Journois D, Parlato M, Moucadel V, Cavaillon JM, Coste J; CAPTAIN Study Group. Clustering ICU patients with sepsis based on the patterns of their circulating biomarkers: A secondary analysis of the CAPTAIN prospective multicenter cohort study. PLoS One. 2022 Oct 27;17(10):e0267517. doi: 10.1371/journal.pone.0267517. eCollection 2022.

    PMID: 36301921DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urin, CSF, BAL

MeSH Terms

Conditions

SepsisShock, SepticInfectionsDisease

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • François J Philippart, MD; PhD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 9, 2011

First Posted

June 22, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

October 17, 2017

Record last verified: 2017-03

Locations

FR(1)