Platelet-associated Inflammation in Severe Sepsis

NCT ID: NCT03029039

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-02
• Study Completion Date: 2019-07-05

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with severe sepsis

Blood samples will be collected at inclusion.

Blood samples

Intervention Type: OTHER

Blood samples will be collected at inclusion.

patients with inflammatory syndrome without sepsis

Blood samples will be collected at inclusion.

Blood samples

Intervention Type: OTHER

Blood samples will be collected at inclusion.

blood donor voluntary

Blood samples will be collected.

Blood samples

Intervention Type: OTHER

Blood samples will be collected at inclusion.

Interventions

Blood samples

Blood samples will be collected at inclusion.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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 a platelet transfusion in the week before inclusion or 72 hours after a surgical gesture or the occurrence of sepsis
• Patients with the platelet account is less than 30 000 per cubic millimeter the day of the sampling
• Patients with a severe sepsis who had a surgical gesture previous week the inclusion
• All clinical sequelae or biological at the selection
• pregnant woman
• Patients with a treatment by platelet aggregation has continued throughout severe sepsis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Agency, France

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phillipe BERTHELOT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

Chu Saint-Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

1608110

Identifier Type: -

Identifier Source: org_study_id