Following of Myeloid-derived Suppressor Cells (MDSC) in Severe Sepsis: What Relationship With Systemic Inflammatory Syndrome?

NCT ID: NCT02903082

Last Updated: 2019-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-01-31

Brief Summary

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Sepsis remains a major cause of death in developed countries. A better understanding of the mechanisms involved in the regulation of inflammatory and immune response of patients with severe sepsis is an important step that could open the way for new therapeutic approaches.

Detailed Description

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Conditions

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Severe Sepsis Inflammatory Response Syndrome, Systemic

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

Patient hospitalized in intensive care for sepsis evolving for less than 48 hours with two criteria of systemic inflammatory response syndrome

Residue of blood further to NFS

Intervention Type BIOLOGICAL

Bone marrow collected during myelogram routinely performed during hospitalization in ICU

Intervention Type BIOLOGICAL

Control

10 Patients hospitalized for a hematologic pathology workup considered normal by two haematologists and 10 patients hospitalized for a preoperative workup.

Residue of blood further to preoperative workup

Intervention Type BIOLOGICAL

Bone marrow collected during a myelogram carried out for hematological pathology workup

Intervention Type BIOLOGICAL

Interventions

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Residue of blood further to NFS

Intervention Type BIOLOGICAL

Residue of blood further to preoperative workup

Intervention Type BIOLOGICAL

Bone marrow collected during a myelogram carried out for hematological pathology workup

Intervention Type BIOLOGICAL

Bone marrow collected during myelogram routinely performed during hospitalization in ICU

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patient ≥18 years old
* Patient with two criteria of systemic inflammatory response syndrome and one of the four following criteria within 24 hours of hospitalization in ICU:

* Lactate \>4 mmol/L
* PaO2 / FiO2 \<200 in the presence of lung disease as infectious source
* Vasopressor: adrenaline or noradrenaline ≥0.25 µg/kg/min for at least 6 hours to maintain a systolic blood pressure ≥90 mmHg or mean arterial pressure ≥65 mmHg
* Thrombocytopenia linked to sepsis with platelet count \<100,000 / ml or a decrease ≤50% within 48 hours

Exclusion Criteria

* Pregnancy
* progressive solid cancer
* HIV infection
* History of blood or inflammatory disease
* long-term immunosuppressive treatment
* Prior episode of Sepsis in the previous month
* Chronic Dialysis Patient
* Patient under guardianship
* Patient not affiliated with a social security system
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de LIMOGES

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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I16019 (MDSC)

Identifier Type: -

Identifier Source: org_study_id

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