Platelet-associated Inflammation in Severe Sepsis

NCT03029039 | Completed

• 2 other identifiers: 1608110ID-RCB
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis represents a serious public health issue characterized by a complex inflammatory response. In addition to their hemostatic role, platelets display inflammatory functions by secreting a variety of immunomodulatory factors and interacting with circulating immune cells. The investigators postulate that, in severe sepsis, platelets become activated and release amounts of different soluble inflammatory molecules that contribute to sepsis-associated inflammation. First, the investigators propose to assess whether severe sepsis impairs the ability of platelets to release soluble CD40L (sCD40L), an powerful platelet-derived immunomodulatory molecule, in ICU patients with S. aureus documented infection, ICU patients with documented infection involving other bacterial species, compared to ICU patients with inflammation of noninfectious origin and healthy blood donors. Then, the investigators wish to assess whether the bacterial species affects the release of platelet sCD40L and by an extensive screening of platelet soluble factors, the investigators propose to set up profiles of inflammatory molecules associated with the type of infection. Finally, the investigators will analyze platelets' activation state and their association with circulating immune, according to the type of infection. Therefore, this project is expected to assess to which extent the platelet inflammatory function is super-activated in severe sepsis and to identify new platelet-related biomarkers of sepsis.

Conditions

Severe Sepsis

Keywords

Platelet; severe sepsis; inflammation; S. aureus; biomarkers

Outcome Measures

Primary Outcomes (1)

• Comparison of proportion of CD40L between the 3 groups

  Comparison of proportion of CD40L in Platelet-rich plasma (PRP) between the 3 groups by proteomics technique Luminex® stimulated by Thrombin Receptor Activator Peptide (TRAP)-6).

  1 year

Secondary Outcomes (3)

• Comparison of proportion of CD40L between patients with severe sepsis and blood donor voluntary

  1 year

• Comparison of proportion of CD40Lbetween patients with severe sepsis and patients with inflammatory syndrome without sepsis

  1 year

• Proportion of CD40L

  1 year

Study Arms (3)

patients with severe sepsis

Blood samples will be collected at inclusion.

Other: Blood samples

patients with inflammatory syndrome without sepsis

Blood samples will be collected at inclusion.

Other: Blood samples

blood donor voluntary

Blood samples will be collected.

Other: Blood samples

Interventions

Blood samples OTHER

Blood samples will be collected at inclusion.

blood donor voluntary; patients with inflammatory syndrome without sepsis; patients with severe sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe sepsis

You may qualify if:

• Criteria for blood donor voluntary : to weigh more than 50 kg
• Criteria for severe sepsis group : Sepsis with failure of at least one organ, severe sepsis for less than 72 hours, sepsis with bacteria S. aureus, S. pneumoniae or E. coli.
• Criteria for uninfectious inflammatory syndrome group : patients operate since less than 24 hours of hip or knee surgery, Absence of systemic infection

You may not qualify if:

• failure to participate at the study
• Patients with a aspirin treatment has continued throughout severe sepsis
• Patients with an appropriate antibiotic therapy for more than 72 hours
• Patients with the platelet account is less than 30 000 per cubic millimeter the day of the sampling
• All clinical sequelae or biological at the selection
• pregnant woman
• Patients with a treatment by platelet aggregation has continued throughout severe sepsis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• National Research Agency, France: collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Sepsis; Inflammation; Staphylococcal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Phillipe BERTHELOT, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: February 2, 2017
• Primary Completion: July 5, 2019
• Study Completion: July 5, 2019
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)