Severe SepsisMDSCNCT02903082
Following of Myeloid-derived Suppressor Cells (MDSC) in Severe Sepsis: What Relationship With Systemic Inflammatory Syndrome?
An observational study of Severe Sepsis and Inflammatory Response Syndrome, Systemic, run by University Hospital, Limoges at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Inflammatory Response Syndrome, Systemic
- What is being tested?
- Residue of blood further to NFS, Residue of blood further to preoperative workup and Bone marrow collected during a myelogram carried out for hematological pathology workup
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient hospitalized in intensive care for sepsis evolving for less than 48 hours with two criteria of systemic inflammatory response syndrome
Who may be able to join
- 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
Who cannot join
- Pregnancy
- progressive solid cancer
- HIV infection
- History of blood or inflammatory disease
- long-term immunosuppressive treatment
- Prior episode of Sepsis in the previous month
Show all 9Show fewer
- Chronic Dialysis Patient
- Patient under guardianship
- Patient not affiliated with a social security system
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- 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
- Keywords
- Myeloid-Derivated suppressive cell, Sepsis, Inflammatory Response Syndrome, Systemic
- Medical subject headings
- Sepsis, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residue of blood further to NFSBiological
Residue of blood further to preoperative workupBiological
Bone marrow collected during a myelogram carried out for hematological pathology workupBiological
Bone marrow collected during myelogram routinely performed during hospitalization in ICUBiological
| Study group | Role | What they receive |
|---|---|---|
| Case | Patient hospitalized in intensive care for sepsis evolving for less than 48 hours with two criteria of systemic inflammatory response syndrome Receives: Biological: Residue of blood further to NFS; Biological: Bone marrow collected during myelogram routinely performed during hospitalization in ICU | |
| Control | 10 Patients hospitalized for a hematologic pathology workup considered normal by two haematologists and 10 patients hospitalized for a preoperative workup. Receives: Biological: Residue of blood further to preoperative workup; Biological: Bone marrow collected during a myelogram carried out for hematological pathology workup |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Average 30 days - Patients will be followed up until hospital discharge
Secondary outcomes (7)
Immuno- inflammatory status
Pro-inflammatory cytokines determined by flow cytometry
Measured: Day 0, Day3, Day 7 and once a week until the intensive care unit discharge
MDSCs presence in the blood and bone marrow.
Concentration of MDSC in the blood determined by flow cytometry
Measured: Day 0
Assessment of MDSC specific gene expressions
Measurement of MDSC activation by real-time qRT-PCRMDSC cell culture
Measured: Day 0 vs Days 3, 7, 14, 21, 28
Assessment of MDSC functional status
Inhibition of T cell proliferation capacity (co-culture assay in vitro)MDSC cell culture
Measured: Day 0 vs Days 3, 7, 14, 21, 28
Mortality
Dead or alive
Measured: Day 28 and Day 90
Incidence of hospital acquired secondary infections at Day 28
Incidence of hospital acquired secondary infections at Day 28
Measured: Day 28
SOFA score
Calculating of SOFA score
Measured: Day 0, Day3, Day 7 and once a week until the intensive care unit discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startApr 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903082
- Sponsor's protocol ID
- I16019 (MDSC)
- Acronym
- MDSC
- Status last verified
- Jan 2019
- First submitted
- 2 Sep 2016
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Following of Myeloid-derived Suppressor Cells (MDSC) in Severe Sepsis: What Relationship With Systemic Inflammatory Syndrome?
- ClinicalTrials.gov ID
- NCT02903082
- Acronym / sponsor ID
- MDSC / I16019 (MDSC)
- Keywords
- Myeloid-Derivated suppressive cell, Sepsis, Inflammatory Response Syndrome, Systemic
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Biological: Residue of blood further to NFS, Biological: Bone marrow collected during myelogram routinely performed during hospitalization in ICUPatient hospitalized in intensive care for sepsis evolving for less than 48 hours with two criteria of systemic inflammatory response syndrome |
| Control | – | Biological: Residue of blood further to preoperative workup, Biological: Bone marrow collected during a myelogram carried out for hematological pathology workup10 Patients hospitalized for a hematologic pathology workup considered normal by two haematologists and 10 patients hospitalized for a preoperative workup. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in intensive care for sepsis evolving for less than 48 hours with two criteria of systemic inflammatory response syndrome
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (9 listed)
- Pregnancy
- progressive solid cancer
- HIV infection
- History of blood or inflammatory disease
- long-term immunosuppressive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Residue of blood further to NFS | Biological | Case |
| Residue of blood further to preoperative workup | Biological | Control |
| Bone marrow collected during a myelogram carried out for hematological pathology workup | Biological | Control |
| Bone marrow collected during myelogram routinely performed during hospitalization in ICU | Biological | Case |
Primary outcome
Change in Peripheral Blood MDSC concentration during ICU hospitalization for Severe Sepsis
Time frame: Average 30 days - Patients will be followed up until hospital discharge
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)
7 secondary outcomes
Immuno- inflammatory status
Time frame: Day 0, Day3, Day 7 and once a week until the intensive care unit discharge
MDSCs presence in the blood and bone marrow.
Time frame: Day 0
Assessment of MDSC specific gene expressions
Time frame: Day 0 vs Days 3, 7, 14, 21, 28
Assessment of MDSC functional status
Time frame: Day 0 vs Days 3, 7, 14, 21, 28
Mortality
Time frame: Day 28 and Day 90
Incidence of hospital acquired secondary infections at Day 28
Time frame: Day 28
SOFA score
Time frame: Day 0, Day3, Day 7 and once a week until the intensive care unit discharge
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Inflammatory Response Syndrome, Systemic, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peripheral Blood MDSC concentration during ICU hospitalization for Severe Sepsis (time frame: Average 30 days - Patients will be followed up until hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2019.