Systemic Inflammatory Response SyndromeAOSISNCT06028789
AOrtic Surgery: Systemic Inflammatory Response Versus Sepsis
An observational study of Systemic Inflammatory Response Syndrome and Infections, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
The goal of the prospective observational study is to evaluate the immunological background of inflammatory response often seen after open thoracic aortic surgery. Patients scheduled for this type of procedure will undergo a series of blood testing (preoperatively, and several times postoperatively). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Infections, Thoracic Aortic Aneurysm
- What is being tested?
- Blood sample test and Thoracic Aortic Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2022to 30 Jun 2024
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study group is defined as patients scheduled for elective replacement of thoracic aorta of any extent by artificial vascular graft, including Bentall procedure,valve-sparing root replacement, supracoronary aortic replacement, also Ross procedure with supracoronary aortic replacement, hemiarch and total aortic arch replacement. Control group is defined as patients admitted to our institution with active infectious endocarditis.
Who may be able to join
- patient scheduled for elective replacement of thoracic aorta of any extent by artificial vascular graft, including Bentall procedure, Yacoub procedure, supracoronary aortic replacement, also Ross procedure with supracoronary aortic replacement, hemiarch and total aortic arch replacement
- signature of informed patient consent
- patient with active infectious endocarditis
- signature of informed patient consent
Who cannot join
- active endocarditis or other infection
- unstable preoperative condition
- more than 5 days since diagnosis
Trial locations and contacts
1 site in 1 country.
Andrej Myjavec, MD contact
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Hradec Králové
Hradec Králové, Královehradecký Kraj, 500 02
Ján Gofus, MD, PhD, +420495832422, jan.gofus@fnhk.cz
Andrej Myjavec, MD
About this study
Official title: Differential Diagnosis of Sterile Systemic Inflammation and Sepsis in Patients Undergoing Thoracic Aortic Surgery
The goal of the prospective observational study is to evaluate the immunological background of inflammatory response often seen after open thoracic aortic surgery. Patients scheduled for this type of procedure will undergo a series of blood testing (preoperatively, and several times postoperatively). The blood samples will be used for a wide scale of immunological tests to better evaluate potential differential markers against infection. A control group will include patients with active infective endocarditis (preoperatively).
The main question is if there is a biomarker able to determine a difference between sterile systemic inflammation and infection after thoracic aortic surgery. The second question is if there is a difference in dynamics of evaluated biomarkers between sterile postoperative inflammation and active endocarditis.
Read the detailed description
It has been observed in daily clinical practice that patients after thoracic aortic replacement (of any extent, of any reason) often develop a set of specific symptoms. Those include fever, weakness and prolonged rise of standard laboratory parameters of inflammation (CRP and leucocyte level) in absence of infection. Those symptoms may, but do not have to, coincide with typical signs of postcardiotomy syndrome, rather characteristic by pericardial / pleural effusion and indifferent chest pain. They rather resemble a so called "postimplantation" syndrome, described after endovascular aortic repair. As a reaction to foreign vascular graft material, pro-inflammatory cytokines are being released, thus leading to flu-like symptoms in absence of true infection. Those occur in the short-term postoperatively, usually in the first 2 weeks after the surgery.
Patients after thoracic aortic surgery represent a high-risk patient cohort vulnerable to infections of any kind, mostly respiratory, urinary, wound infections, and, last but not least, early valve endocarditis / endoaortitis being the most feared of them. While clinicians (and patients) are often afraid of the abovementioned complications, the patients are forced to undergo complex diagnostic process including repeated echocardiography, collection of microbiology cultures and blood samples, chest computer tomography imaging with extensive radiation burden. The prolonged broad-spectrum empiric antibiotic treatment is often in place together with prolonged hospital stay and limited patient satisfaction. The question of starting the immunosuppressive treatment is often weighed against the potential aggravation of infection with eventual fatal consequences.
In absence of a specific biomarker to distinguish between the sterile systemic inflammation and infection, the clinicians must rely on complex evaluation of patient symptoms, clinical examination, imaging modalities, standard laboratory measures of inflammation and microbiology cultures (with some delay). However, in the era of molecular biology and extensive progress in immunology research, there has been a long row of potential biomarkers able to specify the etiology of inflammatory process significantly sooner.
The potential biomarkers of inflammation suitable for this issue are mentioned in detail further. Conventional biomarkers include CRP, leukocyte count, differential blood count, recently also procalcitonin (PCT), tumor necrosis factor-α (TNF- α) and interleukin-6 (IL-6). Hematology tests have reported novel early markers of sepsis, e.g. mean neutrophil volume or neutrophil-to-lymphocyte ratio. Novel serology markers (mostly assessed by ELISA) include soluble triggering receptor expressed on myeloid cell-1 (sTREM-1), presepsin, serum amyloid-A, pentraxin 3, hemoxygenase-1 (HO-1), soluble CD64 (sCD64), soluble CD163 (sCD163), high mobility group box-1 (HMGB-1), lipopolysaccharide-binding protein (LBP) and others. Newly, the molecules expressed on the surface of circulating blood cells may be examined using flow cytometry: CD64 on polymorphonuclears (PMN CD64 index) or monocytes, CD163, CD167, HLA-DR etc. Cell function assays which test ability of blood cells to respond to microbial stimuli (represented by LPS, flagellin, etc.) may reveal changes in soluble biomarkers, such as IL-18 or IFN-γ that reflect nature of inflammation in patients.
Recently, several scoring systems have emerged combining panels of various biomarkers. There is a promising evidence for a composite of serum and cell-expressed parameters, called "Bioscore", including procalcitonin, sTREM-1 and PMN CD64 index. A composite of 5 hematological parameters has proven to be a reliable marker of early sepsis, being called intensive care infection score (ICIS). Another scoring systems have been developed by group of Kofoed et al. Nevertheless, most of these scoring systems have been tested in the settings of unstable patients in the intensive care unit. The issue of inflammatory response described above is mostly a matter of stable patients in the standard ward who develop signs of undetermined inflammation. Eventual diagnostic modalities in these settings have been only scarcely evaluated before. The topic of inflammatory response after aortic surgery (IRAS) has not been studied in the literature yet.
- Conditions
- Systemic Inflammatory Response Syndrome, Infections, Thoracic Aortic Aneurysm, Aortic Diseases, Immunological Abnormality
- Being tested
- Blood sample test, Thoracic Aortic Surgery
- Keywords
- systemic inflammatory response syndrome, infection, thoracic aortic surgery
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Infections, Aortic Aneurysm, Thoracic, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample testDiagnostic test
The following groups of biomarkers will be examined:
- standard panel of inflammation markers: CRP, PCT, IL-6, Leukocyte count, differential blood count
- microbiology cultures according to the clinical status
- serum biomarkers: sCD64, sTREM-1, calprotectin, pentraxin 3
- flow cytometry: HLA-DR, CD14, CD16, CD40, CD45, CD64, CD163 expression on granulocytes and monocytes
- cell function assay: IL-18 and IFN-γ
- hematology: ICIS, Neutrophil-to-lymphocyte ratio - examined together with conventional hematological parameters.
The schedule of blood sample taking will be as follows:
- the study group: preoperatively (T-1), 1st postoperative day (T1), 3rd postoperative day (T2), 7th postoperative day (T3), 10th postoperative day (T4)
- the control group: at admission or the next day (T1), 3rd day of hospital stay (T2), 7th day of hospital stay (T3), 10th day of hospital stay (T4)
Thoracic Aortic SurgeryProcedure or surgery
Scheduled surgical intervention, i.e. replacement of pre-specified part of thoracic aorta by a vascular prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients undergoing elective thoracic aortic surgery. Receives: Diagnostic Test: Blood sample test; Procedure: Thoracic Aortic Surgery | |
| Control group | Patients admitted to our institution with active infectious endocarditis. Receives: Diagnostic Test: Blood sample test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of sCD64
A statistically significant difference in absolute value or dynamics of serum concentrations of sCD64 between the study groups to help distinguish between the specified clinical syndromes.
Measured: After completion of the study - until the end of 2023
Expression of CD64 on granulocytes
A statistically significant difference in absolute values or dynamics of the expression of CD64 on granulocytes between the study groups to distinguish between the specified clinical syndromes. Expression on monocytes will be also assessed.
Measured: After completion of the study - until the end of 2023
Cell function assay of INF-γ
A significant difference in the outcomes of cell function assay of INF-γ between the study groups to distinguish between the specified clinical syndromes.
Measured: After completion of the study - until the end of 2023
Secondary outcomes (11)
Serum concentration of sTREM-1
A statistically significant difference in absolute value or dynamics of serum concentrations of sTREM-1 between the study groups to help distinguish between the specified clinical syndromes.
Measured: After completion of the study - until the end of 2023
Serum concentration of calprotectin
A statistically significant difference in absolute value or dynamics of serum concentrations of calprotectin between the study groups to help distinguish between the specified clinical syndromes.
Measured: After completion of the study - until the end of 2023
Serum concentration of pentraxin 3
A statistically significant difference in absolute value or dynamics of serum concentrations of pentraxin 3 between the study groups to help distinguish between the specified clinical syndromes.
Measured: After completion of the study - until the end of 2023
Expression of HLA-DR on granulocytes
A statistically significant difference in absolute values or dynamics of the expression of HLA-DR on granulocytes between the study groups to distinguish between the specified clinical syndromes. Expression on monocytes will be also assessed.
Measured: After completion of the study - until the end of 2023
Expression of CD-14 on granulocytes
A statistically significant difference in absolute values or dynamics of the expression of CD-14 on granulocytes between the study groups to distinguish between the specified clinical syndromes. Expression on monocytes will be also assessed.
Measured: After completion of the study - until the end of 2023
Expression of CD-16 on granulocytes
A statistically significant difference in absolute values or dynamics of the expression of CD-16 on granulocytes between the study groups to distinguish between the specified clinical syndromes. Expression on monocytes will be also assessed.
Measured: After completion of the study - until the end of 2023
Expression of CD-40 on granulocytes
A statistically significant difference in absolute values or dynamics of the expression of CD-40 on granulocytes between the study groups to distinguish between the specified clinical syndromes. Expression on monocytes will be also assessed.
Measured: After completion of the study - until the end of 2023
Expression of CD-45 on granulocytes
A statistically significant difference in absolute values or dynamics of the expression of CD-45 on granulocytes between the study groups to distinguish between the specified clinical syndromes. Expression on monocytes will be also assessed.
Measured: After completion of the study - until the end of 2023
Expression of CD-163 on granulocytes
A statistically significant difference in absolute values or dynamics of the expression of CD-163 on granulocytes between the study groups to distinguish between the specified clinical syndromes. Expression on monocytes will be also assessed.
Measured: After completion of the study - until the end of 2023
Cell function assay of IL-18
A significant difference in the outcomes of cell function assay of IL-18 between the study groups to distinguish between the specified clinical syndromes.
Measured: After completion of the study - until the end of 2023
ICIS score
A significant difference in the absolute values or dynamics of ICIS (intensive care infection score) score value between the study groups.
Measured: After completion of the study - until the end of 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Apr 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Collaborators
- American Association for Thoracic Surgery
- Responsible party
- Sponsor
- Investigators
- Jan Vojacek, Prof. MD, Study chair, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028789
- Sponsor's protocol ID
- 202202 P02
- Acronym
- AOSIS
- Status last verified
- May 2024
- First submitted
- 22 May 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gabaldo K, Sutlic Z, Miskovic D, Knezevic Pravecek M, Prvulovic D, Vujeva B, Cvitkusic Lukenda K, Hadzibegovic I. Postpericardiotomy syndrome incidence, diagnostic and treatment strategies: experience AT two collaborative centers. Acta Clin Croat. 2019 Mar;58(1):57-62. doi: 10.20471/acc.2019.58.01.08.
PubMed 31363326Daye D, Walker TG. Complications of endovascular aneurysm repair of the thoracic and abdominal aorta: evaluation and management. Cardiovasc Diagn Ther. 2018 Apr;8(Suppl 1):S138-S156. doi: 10.21037/cdt.2017.09.17.
PubMed 29850426Raveendran AV, Kumar A, Gangadharan S. Biomarkers and newer laboratory investigations in the diagnosis of sepsis. J R Coll Physicians Edinb. 2019 Sep;49(3):207-216. doi: 10.4997/JRCPE.2019.308.
PubMed 31497788Gibot S, Bene MC, Noel R, Massin F, Guy J, Cravoisy A, Barraud D, De Carvalho Bittencourt M, Quenot JP, Bollaert PE, Faure G, Charles PE. Combination biomarkers to diagnose sepsis in the critically ill patient. Am J Respir Crit Care Med. 2012 Jul 1;186(1):65-71. doi: 10.1164/rccm.201201-0037OC. Epub 2012 Apr 26.
PubMed 22538802Nierhaus A, Linssen J, Wichmann D, Braune S, Kluge S. Use of a weighted, automated analysis of the differential blood count to differentiate sepsis from non-infectious systemic inflammation: the intensive care infection score (ICIS). Inflamm Allergy Drug Targets. 2012 Apr;11(2):109-15. doi: 10.2174/187152812800392841.
PubMed 22280231Kofoed K, Andersen O, Kronborg G, Tvede M, Petersen J, Eugen-Olsen J, Larsen K. Use of plasma C-reactive protein, procalcitonin, neutrophils, macrophage migration inhibitory factor, soluble urokinase-type plasminogen activator receptor, and soluble triggering receptor expressed on myeloid cells-1 in combination to diagnose infections: a prospective study. Crit Care. 2007;11(2):R38. doi: 10.1186/cc5723.
PubMed 17362525Djebara S, Biston P, Fosse E, Daper A, Joris M, Boudjeltia KZ, Lelubre C, Cauchie P, Piagnerelli M. Time Course of CD64, a Leukocyte Activation Marker, During Cardiopulmonary Bypass Surgery. Shock. 2017 Feb;47(2):158-164. doi: 10.1097/SHK.0000000000000751.
PubMed 27648690Kolackova M, Kudlova M, Kunes P, Lonsky V, Mandak J, Andrys C, Jankovicova K, Krejsek J. Early expression of FcgammaRI (CD64) on monocytes of cardiac surgical patients and higher density of monocyte anti-inflammatory scavenger CD163 receptor in "on-pump" patients. Mediators Inflamm. 2008;2008:235461. doi: 10.1155/2008/235461.
PubMed 18320015
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnosis of Sterile Systemic Inflammation and Sepsis in Patients Undergoing Thoracic Aortic Surgery
- ClinicalTrials.gov ID
- NCT06028789
- Acronym / sponsor ID
- AOSIS / 202202 P02
- Conditions
- Systemic Inflammatory Response Syndrome, Infections, Thoracic Aortic Aneurysm, Aortic Diseases, Immunological Abnormality
- Keywords
- systemic inflammatory response syndrome, infection, thoracic aortic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Collaborators
- American Association for Thoracic Surgery
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 8 Sep 2023 (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.
The goal of the prospective observational study is to evaluate the immunological background of inflammatory response often seen after open thoracic aortic surgery. Patients scheduled for this type of procedure will undergo a series of blood testing (preoperatively, and several times postoperatively). The blood samples will be used for a wide scale of immunological tests to better evaluate potential differential markers against infection. A control group will include patients with active infective endocarditis (preoperatively).
The main question is if there is a biomarker able to determine a difference between sterile systemic inflammation and infection after thoracic aortic surgery. The second question is if there is a difference in dynamics of evaluated biomarkers between sterile postoperative inflammation and active endocarditis.
Detailed description
It has been observed in daily clinical practice that patients after thoracic aortic replacement (of any extent, of any reason) often develop a set of specific symptoms. Those include fever, weakness and prolonged rise of standard laboratory parameters of inflammation (CRP and leucocyte level) in absence of infection. Those symptoms may, but do not have to, coincide with typical signs of postcardiotomy syndrome, rather characteristic by pericardial / pleural effusion and indifferent chest pain. They rather resemble a so called "postimplantation" syndrome, described after endovascular aortic repair. As a reaction to foreign vascular graft material, pro-inflammatory cytokines are being released, thus leading to flu-like symptoms in absence of true infection. Those occur in the short-term postoperatively, usually in the first 2 weeks after the surgery.
Patients after thoracic aortic surgery represent a high-risk patient cohort vulnerable to infections of any kind, mostly respiratory, urinary, wound infections, and, last but not least, early valve endocarditis / endoaortitis being the most feared of them. While clinicians (and patients) are often afraid of the abovementioned complications, the patients are forced to undergo complex diagnostic process including repeated echocardiography, collection of microbiology cultures and blood samples, chest computer tomography imaging with extensive radiation burden. The prolonged broad-spectrum empiric antibiotic treatment is often in place together with prolonged hospital stay and limited patient satisfaction. The question of starting the immunosuppressive treatment is often weighed against the potential aggravation of infection with eventual fatal consequences.
In absence of a specific biomarker to distinguish between the sterile systemic inflammation and infection, the clinicians must rely on complex evaluation of patient symptoms, clinical examination, imaging modalities, standard laboratory measures of inflammation and microbiology cultures (with some delay). However, in the era of molecular biology and extensive progress in immunology research, there has been a long row of potential biomarkers able to specify the etiology of inflammatory process significantly sooner.
The potential biomarkers of inflammation suitable for this issue are mentioned in detail further. Conventional biomarkers include CRP, leukocyte count, differential blood count, recently also procalcitonin (PCT), tumor necrosis factor-α (TNF- α) and interleukin-6 (IL-6). Hematology tests have reported novel early markers of sepsis, e.g. mean neutrophil volume or neutrophil-to-lymphocyte ratio. Novel serology markers (mostly assessed by ELISA) include soluble triggering receptor expressed on myeloid cell-1 (sTREM-1), presepsin, serum amyloid-A, pentraxin 3, hemoxygenase-1 (HO-1), soluble CD64 (sCD64), soluble CD163 (sCD163), high mobility group box-1 (HMGB-1), lipopolysaccharide-binding protein (LBP) and others. Newly, the molecules expressed on the surface of circulating blood cells may be examined using flow cytometry: CD64 on polymorphonuclears (PMN CD64 index) or monocytes, CD163, CD167, HLA-DR etc. Cell function assays which test ability of blood cells to respond to microbial stimuli (represented by LPS, flagellin, etc.) may reveal changes in soluble biomarkers, such as IL-18 or IFN-γ that reflect nature of inflammation in patients.
Recently, several scoring systems have emerged combining panels of various biomarkers. There is a promising evidence for a composite of serum and cell-expressed parameters, called "Bioscore", including procalcitonin, sTREM-1 and PMN CD64 index. A composite of 5 hematological parameters has proven to be a reliable marker of early sepsis, being called intensive care infection score (ICIS). Another scoring systems have been developed by group of Kofoed et al. Nevertheless, most of these scoring systems have been tested in the settings of unstable patients in the intensive care unit. The issue of inflammatory response described above is mostly a matter of stable patients in the standard ward who develop signs of undetermined inflammation. Eventual diagnostic modalities in these settings have been only scarcely evaluated before. The topic of inflammatory response after aortic surgery (IRAS) has not been studied in the literature yet.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Blood sample test, Procedure: Thoracic Aortic SurgeryPatients undergoing elective thoracic aortic surgery. |
| Control group | – | Diagnostic Test: Blood sample testPatients admitted to our institution with active infectious endocarditis. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study group is defined as patients scheduled for elective replacement of thoracic aorta of any extent by artificial vascular graft, including Bentall procedure,valve-sparing root replacement, supracoronary aortic replacement, also Ross procedure with supracoronary aortic replacement, hemiarch and total aortic arch replacement. Control group is defined as patients admitted to our institution with active infectious endocarditis.
Key inclusion criteria (4 listed)
- patient scheduled for elective replacement of thoracic aorta of any extent by artificial vascular graft, including Bentall procedure, Yacoub procedure, supracoronary aortic replacement, also Ross procedure with supracoronary aortic replacement, hemiarch and total aortic arch replacement
- signature of informed patient consent
- patient with active infectious endocarditis
- signature of informed patient consent
Key exclusion criteria (3 listed)
- active endocarditis or other infection
- unstable preoperative condition
- more than 5 days since diagnosis
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 |
|---|---|---|
| Blood sample testThe following groups of biomarkers will be examined: * standard panel of inflammation markers: CRP, PCT, IL-6, Leukocyte count, differential blood count * microbiology cultures according to the clinical status * serum biomarkers: sCD64, sTREM-1, calprotectin, pentraxin 3 * flow cytometry: HLA-DR, CD14, CD16, CD40, CD45, CD64, CD163 expression on granulocytes and monocytes * cell function assay: IL-18 and IFN-γ * hematology: ICIS, Neutrophil-to-lymphocyte ratio - examined together with conventional hematological parameters. The schedule of blood sample taking will be as follows: A. the study group: preoperatively (T-1), 1st postoperative day (T1), 3rd postoperative day (T2), 7th postoperative day (T3), 10th postoperative day (T4) B. the control group: at admission or the next day (T1), 3rd day of hospital stay (T2), 7th day of hospital stay (T3), 10th day of hospital stay (T4) | Diagnostic test | Control group, Study group |
| Thoracic Aortic SurgeryScheduled surgical intervention, i.e. replacement of pre-specified part of thoracic aorta by a vascular prosthesis. | Procedure or surgery | Study group |
Primary outcome
Serum concentration of sCD64
Time frame: After completion of the study - until the end of 2023
A statistically significant difference in absolute value or dynamics of serum concentrations of sCD64 between the study groups to help distinguish between the specified clinical syndromes.
Expression of CD64 on granulocytes
Time frame: After completion of the study - until the end of 2023
A statistically significant difference in absolute values or dynamics of the expression of CD64 on granulocytes between the study groups to distinguish between the specified clinical syndromes. Expression on monocytes will be also assessed.
Cell function assay of INF-γ
Time frame: After completion of the study - until the end of 2023
A significant difference in the outcomes of cell function assay of INF-γ between the study groups to distinguish between the specified clinical syndromes.
11 secondary outcomes
Serum concentration of sTREM-1
Time frame: After completion of the study - until the end of 2023
Serum concentration of calprotectin
Time frame: After completion of the study - until the end of 2023
Serum concentration of pentraxin 3
Time frame: After completion of the study - until the end of 2023
Expression of HLA-DR on granulocytes
Time frame: After completion of the study - until the end of 2023
Expression of CD-14 on granulocytes
Time frame: After completion of the study - until the end of 2023
Expression of CD-16 on granulocytes
Time frame: After completion of the study - until the end of 2023
Expression of CD-40 on granulocytes
Time frame: After completion of the study - until the end of 2023
Expression of CD-45 on granulocytes
Time frame: After completion of the study - until the end of 2023
Expression of CD-163 on granulocytes
Time frame: After completion of the study - until the end of 2023
Cell function assay of IL-18
Time frame: After completion of the study - until the end of 2023
ICIS score
Time frame: After completion of the study - until the end of 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 31363326Gabaldo K, Sutlic Z, Miskovic D, Knezevic Pravecek M, Prvulovic D, Vujeva B, Cvitkusic Lukenda K, Hadzibegovic I. Postpericardiotomy syndrome incidence, diagnostic and treatment strategies: experience AT two collaborative centers. Acta Clin Croat. 2019 Mar;58(1):57-62. doi: 10.20471/acc.2019.58.01.08.
- Background: PubMed 29850426Daye D, Walker TG. Complications of endovascular aneurysm repair of the thoracic and abdominal aorta: evaluation and management. Cardiovasc Diagn Ther. 2018 Apr;8(Suppl 1):S138-S156. doi: 10.21037/cdt.2017.09.17.
- Background: PubMed 31497788Raveendran AV, Kumar A, Gangadharan S. Biomarkers and newer laboratory investigations in the diagnosis of sepsis. J R Coll Physicians Edinb. 2019 Sep;49(3):207-216. doi: 10.4997/JRCPE.2019.308.
- Background: PubMed 22538802Gibot S, Bene MC, Noel R, Massin F, Guy J, Cravoisy A, Barraud D, De Carvalho Bittencourt M, Quenot JP, Bollaert PE, Faure G, Charles PE. Combination biomarkers to diagnose sepsis in the critically ill patient. Am J Respir Crit Care Med. 2012 Jul 1;186(1):65-71. doi: 10.1164/rccm.201201-0037OC. Epub 2012 Apr 26.
- Background: PubMed 22280231Nierhaus A, Linssen J, Wichmann D, Braune S, Kluge S. Use of a weighted, automated analysis of the differential blood count to differentiate sepsis from non-infectious systemic inflammation: the intensive care infection score (ICIS). Inflamm Allergy Drug Targets. 2012 Apr;11(2):109-15. doi: 10.2174/187152812800392841.
- Background: PubMed 17362525Kofoed K, Andersen O, Kronborg G, Tvede M, Petersen J, Eugen-Olsen J, Larsen K. Use of plasma C-reactive protein, procalcitonin, neutrophils, macrophage migration inhibitory factor, soluble urokinase-type plasminogen activator receptor, and soluble triggering receptor expressed on myeloid cells-1 in combination to diagnose infections: a prospective study. Crit Care. 2007;11(2):R38. doi: 10.1186/cc5723.
- Background: PubMed 27648690Djebara S, Biston P, Fosse E, Daper A, Joris M, Boudjeltia KZ, Lelubre C, Cauchie P, Piagnerelli M. Time Course of CD64, a Leukocyte Activation Marker, During Cardiopulmonary Bypass Surgery. Shock. 2017 Feb;47(2):158-164. doi: 10.1097/SHK.0000000000000751.
- Background: PubMed 18320015Kolackova M, Kudlova M, Kunes P, Lonsky V, Mandak J, Andrys C, Jankovicova K, Krejsek J. Early expression of FcgammaRI (CD64) on monocytes of cardiac surgical patients and higher density of monocyte anti-inflammatory scavenger CD163 receptor in "on-pump" patients. Mediators Inflamm. 2008;2008:235461. doi: 10.1155/2008/235461.
- Individual participant dataSharing planned: No
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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.
Andrej Myjavec, MD contact
Jan Vojacek, Prof. MD study chair
University Hospital Hradec Kralove
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 Infections, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 4 inclusion and 3 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 21 May 2024. 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 Czechia. 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 Jan Gofus, MD, PhD (+420 722 301 527, jan.gofus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of sCD64 (time frame: After completion of the study - until the end of 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06028789, which also lists 8 linked publications.
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 21 May 2024.