SIRS and Bacterial Sepsis Discrimination by Biomarkers in ICU (Captain)
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Purpose
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 |
|---|
|
SIRS Sepsis Severe Sepsis Septic Shock |
| Study Type: | Observational |
| Study Design: | 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 |
- Combination of biomarkers in sepsis [ Time Frame: 3 days ( from D0 to D2) ] [ Designated as safety issue: No ]
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
- Pathogen in human fluids (Blood, BAL, CSF, Urin) [ Time Frame: D0 ] [ Designated as safety issue: No ]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
- mRNA expression during inflammatory process in white blood cells [ Time Frame: D0 to D3 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
SIRS patients
Every patient, without exclusion criteria, presenting with SIRS during an hospitalization in ICU.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 95 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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)
Contacts and Locations| France | |
| Groupe hospitalier Paris Saint Joseph | Recruiting |
| Paris, France, 75014 | |
| Contact: Benoit Misset, MD 144123415 ext +33 bmisset@hpsj.fr | |
| Contact: Francois j Philippart, MD PhD 144127021 ext +33 fphilippart@gmail.com | |
| Principal Investigator: Benoît Misset, MD | |
| Sub-Investigator: Francois j Philippart, MD; PhD | |
| Principal Investigator: | François J Philippart, MD; PhD | Groupe Hospitalier Paris Saint Joseph |
More Information
Publications:
| Responsible Party: | Groupe Hospitalier Paris Saint Joseph |
| ClinicalTrials.gov Identifier: | NCT01378169 History of Changes |
| Other Study ID Numbers: | AOM09143, N° 2010-A00908-31 |
| Study First Received: | May 9, 2011 |
| Last Updated: | October 7, 2011 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
|
Sepsis Severe Sepsis SIRS Septic Shock Inflammatory processes Cytokines HLA-DR HLA type II |
Chemokines TLR expression mRNA expression in whole blood Bacterial DNA detection Prognosis factors Infection Diagnosis |
Additional relevant MeSH terms:
|
Sepsis Toxemia Shock Shock, Septic |
Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013