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

Severe Sepsis Clinical Trial

— MDSC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02903082
• Other study ID #: I16019 (MDSC)
• Status: Terminated
• Start date: April 2015
• Est. completion date: January 2018

Study information

• Verified date: January 2019
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Response Syndrome, Systemic
• Sepsis
• Severe Sepsis
• Syndrome
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

Biological:
• Residue of blood further to NFS

• Residue of blood further to preoperative workup

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

• Bone marrow collected during myelogram routinely performed during hospitalization in ICU

Locations

Country	Name	City	State
France	CHU de LIMOGES	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peripheral Blood MDSC concentration during ICU hospitalization for Severe Sepsis	Number of patients showing an increase of Myeloid derived suppressive cells from baseline at Day 30.; Kinetic of Myeloid derived suppressive cells through weekly measures of Absolute Cell Counts (using flow cytometry)	Average 30 days - Patients will be followed up until hospital discharge
Secondary	Immuno- inflammatory status	Pro-inflammatory cytokines determined by flow cytometry	Day 0, Day3, Day 7 and once a week until the intensive care unit discharge
Secondary	MDSCs presence in the blood and bone marrow.	Concentration of MDSC in the blood determined by flow cytometry	Day 0
Secondary	Assessment of MDSC specific gene expressions	Measurement of MDSC activation by real-time qRT-PCRMDSC cell culture	Day 0 vs Days 3, 7, 14, 21, 28
Secondary	Assessment of MDSC functional status	Inhibition of T cell proliferation capacity (co-culture assay in vitro)MDSC cell culture	Day 0 vs Days 3, 7, 14, 21, 28
Secondary	Mortality	Dead or alive	Day 28 and Day 90
Secondary	Incidence of hospital acquired secondary infections at Day 28	Incidence of hospital acquired secondary infections at Day 28	Day 28
Secondary	SOFA score	Calculating of SOFA score	Day 0, Day3, Day 7 and once a week until the intensive care unit discharge