Systemic Inflammatory Response SyndromeCD64NCT03617796
Prognostic Value of CD64 Marker for Patients in Intensive Care Unit
An observational study of Systemic Inflammatory Response Syndrome and Intensive Care, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Among patients admitted to the intensive care unit (ICU), early recognition of those with the highest risk of death is of paramount importance. Since clinical judgment is sometimes uncertain biomarkers could provide additional information likely to guide critical illness management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Intensive Care
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2018to 31 Dec 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: Patients admitted to the intensive care unit for any reason
Who may be able to join
- Patients admitted to the intensive care unit
Who cannot join
- Neutropenia (<500 neutrophils/mm3)
- Treatment by G-CSF or IFN-γ during the week preceding admission to intensive care
- Age < 18 years
- Pregnancy
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Among patients admitted to the intensive care unit (ICU), early recognition of those with the highest risk of death is of paramount importance. Since clinical judgment is sometimes uncertain biomarkers could provide additional information likely to guide critical illness management. We want to evaluate the prognostic value of leucocyte surface expression of CD64.
Blood samples for CD64 biomarker measurement will be obtained daily during the patient's hospitalization. The primary outcome was all-cause death at D28 after admission
Read the detailed description
Some local or systemic biological markers, using highly specialized techniques, have an interest that remains quite marginal in routine.
Markers of inflammation generally have elevated concentrations in circulating blood, but these increases are not specific for prognosis. This is the case of pro-inflammatory cytokines (TNF, IL-1, IL-6...)[1, 2] and especially, so-called'acute phase' proteins such as C-reactive protein (CRP) and procalcitonin. It is now well established that the rise in the CRP is totally non-specific. With regard to procalcitonin, the published data are far from univocal[3-4], in particular because of the heterogeneity of the populations studied (emergency services, medical services, intensive care).
These conventional biological assays are therefore not very informative and less efficient than the clinical-biological scores used in routine (SAPSII and SOFA).
An alternative diagnostic approach relies on molecular changes in the cellular compartment of innate immunity. Activation of neutrophil polymorphils (PNN) is the result of the pro/anti-inflammatory cytokinic balance and hormonal cascades In other words, the degree of activation of NNPs can be considered as the barometer of the intensity of any acute inflammatory phenomenon. One of the most specific indicators of a systemic inflammatory response is the increased expression of CD64, a high affinity receptor to the immunoglobulin fragment Fcγ, on the surface of PNNs.
CD64 expression elevation is induced in 4-6 hours by numerous cytokines (G-CSF, IFN- γ[5-7]. Given the very low basal expression level of CD64 (less than 2000 sites per cell) and its rate of elevation in case of inflammation, its determination could prove interesting in demonstrating the inflammatory response and its intensity.
In addition, the measurement of CD64 expression has obvious advantages over other PNN activation markers (such as CD11b, CD18, CD16, CD45RA or CD62L): negligible expression in healthy volunteers; no influence of blood sample manipulation; stable expression for 36 hours on anticoagulated blood.
The other decisive advantage is the standardisation and automation of the measurement (performed in flow cytometry) thanks to a device developed by the LeukoDx company, the ACCELLIX-CD64. This measurement is performed in whole blood (30 to 50µL maximum), and the measurement time is short (26 minutes), which makes it particularly attractive in the context of emergency and resuscitation.
- Keywords
- markers CD64
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 28 days after admission
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start10 Sep 2018 (estimated)
- Primary completion9 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- El Mehdi SIAGHY, Mr, Study director, CHRU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617796
- Sponsor's protocol ID
- PSS2017/CD64-GIBOT/MS
- Acronym
- CD64
- Status last verified
- Jul 2018
- First submitted
- 1 Aug 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of CD64 Marker for Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03617796
- Acronym / sponsor ID
- CD64 / PSS2017/CD64-GIBOT/MS
- Keywords
- markers CD64
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Sep 2018 (estimated)
- Primary completion
- 9 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 6 Aug 2018 (actual)
- 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.
Among patients admitted to the intensive care unit (ICU), early recognition of those with the highest risk of death is of paramount importance. Since clinical judgment is sometimes uncertain biomarkers could provide additional information likely to guide critical illness management. We want to evaluate the prognostic value of leucocyte surface expression of CD64.
Blood samples for CD64 biomarker measurement will be obtained daily during the patient's hospitalization. The primary outcome was all-cause death at D28 after admission
Detailed description
Some local or systemic biological markers, using highly specialized techniques, have an interest that remains quite marginal in routine.
Markers of inflammation generally have elevated concentrations in circulating blood, but these increases are not specific for prognosis. This is the case of pro-inflammatory cytokines (TNF, IL-1, IL-6...)[1, 2] and especially, so-called'acute phase' proteins such as C-reactive protein (CRP) and procalcitonin. It is now well established that the rise in the CRP is totally non-specific. With regard to procalcitonin, the published data are far from univocal[3-4], in particular because of the heterogeneity of the populations studied (emergency services, medical services, intensive care).
These conventional biological assays are therefore not very informative and less efficient than the clinical-biological scores used in routine (SAPSII and SOFA).
An alternative diagnostic approach relies on molecular changes in the cellular compartment of innate immunity. Activation of neutrophil polymorphils (PNN) is the result of the pro/anti-inflammatory cytokinic balance and hormonal cascades In other words, the degree of activation of NNPs can be considered as the barometer of the intensity of any acute inflammatory phenomenon. One of the most specific indicators of a systemic inflammatory response is the increased expression of CD64, a high affinity receptor to the immunoglobulin fragment Fcγ, on the surface of PNNs.
CD64 expression elevation is induced in 4-6 hours by numerous cytokines (G-CSF, IFN- γ[5-7]. Given the very low basal expression level of CD64 (less than 2000 sites per cell) and its rate of elevation in case of inflammation, its determination could prove interesting in demonstrating the inflammatory response and its intensity.
In addition, the measurement of CD64 expression has obvious advantages over other PNN activation markers (such as CD11b, CD18, CD16, CD45RA or CD62L): negligible expression in healthy volunteers; no influence of blood sample manipulation; stable expression for 36 hours on anticoagulated blood.
The other decisive advantage is the standardisation and automation of the measurement (performed in flow cytometry) thanks to a device developed by the LeukoDx company, the ACCELLIX-CD64. This measurement is performed in whole blood (30 to 50µL maximum), and the measurement time is short (26 minutes), which makes it particularly attractive in the context of emergency and resuscitation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the intensive care unit for any reason
Key inclusion criteria (1 listed)
- Patients admitted to the intensive care unit
Key exclusion criteria (5 listed)
- Neutropenia (<500 neutrophils/mm3)
- Treatment by G-CSF or IFN-γ during the week preceding admission to intensive care
- Age < 18 years
- Pregnancy
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality at 28 days after admission
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
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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.
El Mehdi SIAGHY, Mr study director
CHRU de NANCY
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 Systemic Inflammatory Response Syndrome and Intensive Care, run by Central Hospital, Nancy, France 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastien GIBOT, professor (0383852970 ext. +33, s.gibot@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 28 days after admission (time frame: 28 days). 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 6 Aug 2018.