SepsisINTELLIGENCENCT03350113
Hemospec Device for Sepsis Diagnosis
A study testing Blood sampling for analysis in people with Sepsis, run by University of Athens at 3 sites in 2 countries.
Trial summary
A diagnostic devise, namely HemoSpec, had been developed that integrates clinical information, along with information on circulating protein biomarkers and the morphology of white blood cells to achieve early diagnosis of sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Blood sampling for analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 2 Oct 2017to 30 Apr 2018
- Phase
- Interventional
- 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
Who may be able to join
- Admission in the Emergency Department
- Age above or equal to 18 years old
- Both genders
- Written consent provided from patients or their first-degree relatives for patients unable to consent
- Considerable risk of death as indicated by the presence of at least one of the following: i) sudden alteration of mental status; ii) systolic blood pressure less than 100 mmHg; and iii) high respiratory rate defined as more than or equal to 22 breaths per minute.
Who cannot join
- Known infection by the human immunodeficiency virus-1
- Acute myocardial infarction as evidenced by the electrocardiographic finding of ST- elevation.
- Single trauma or multiple injuries
- Known pregnancy and breastfeeding
- Patients with a life expectancy of less than 28 days and with limited treatment options
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Greece2 sites
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, 12462
General Hospital of Lamia
Lamia, Phthiotis, 35100
About this study
Official title: Integration of Clinical and Laboratory Information to Generate Technological Advance for the Diagnosis of Sepsis - The Intelligence 2 Trial
A diagnostic devise, namely HemoSpec, had been developed that integrates clinical information, along with information on circulating protein biomarkers and the morphology of white blood cells to achieve early diagnosis of sepsis. The current study is aiming to validate and improve performance of HemoSpec for the rapid assessment of the critically ill patient in the Emergency Department.
Read the detailed description
Sepsis is a life-threating organ dysfunction resulting from the dysregulated response of the host to an infection. It is estimated that 1.5 million people present with sepsis annually in Northern America and another 1.5 million people in Europe; 30 to 50% of them die making sepsis the leading cause of death. The key-point in the management of sepsis is the early resuscitation with broad- spectrum antimicrobials and intravenous fluids, if possible within the first hour. However, it is not easy to achieve this goal, especially among patients assessed in the Emergency Department (ED), as the diagnosis of an infection is often delayed until the patient's laboratory and imaging tests are completed.
In an attempt to improve the failure of physicians for early sepsis recognition in the ED, several markers have been developed. The most widely used biomarkers are the absolute number of neutrophils, C-reactive protein (CRP) and procalcitonin (PCT). HemoSpec is a device capable of incorporating clinical information from the patient with laboratory data. The analysis provides information on white blood cell morphology, CRP, PCT, interleukin (IL) -6 and suPAR. The device software has been created from all of the above information collected from prospective cohorts of patients from Greece and Germany. The diagnostic function of HemoSpec has so far been validated in two Phase II studies. The first study took place in Germany and involved 60 patients (20 controls, 20 with systemic inflammatory response and 20 with sepsis) who were hospitalized at the University Hospital in Jena. The second study is currently being conducted in Greece and aims to use the information from the HemoSpec device for the prospective categorization of patients with confirmed infection in patients with sepsis and in patients without sepsis.
The above two studies share a common Phase II design in order to validate HemoSpec's diagnostic ability among patients who are clinically diagnosed with sepsis. The clinical reliability of HemoSpec can be verified in a multicenter prospective trial involving patients assessed in the ED. The present study aims to assess the diagnostic ability of the device in ED patients with clinical signs of infection who have a significant risk of death that makes them likely to suffer from sepsis.
- Conditions
- Sepsis
- Being tested
- Blood sampling for analysis
- Keywords
- prognosis, diagnosis
- Medical subject headings
- Sepsis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for analysisDevice
Also called Hemospec
Blood Sampling for Analysis
| Study group | Role | What they receive |
|---|---|---|
| HemoSpec | Experimental | Blood Sampling for analysis in the HemoSpec device Receives: Device: Blood sampling for analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of HemoSpec for the diagnosis of sepsis
The sensitivity of HemoSpec output to diagnose the presence of sepsis compared to the absence of sepsis. HemoSpec output will be considered to provide a satisfactory diagnosis of sepsis if sensitivity for the diagnosis is greater than 90%.
Measured: 4 days
Secondary outcomes (2)
Diagnostic performance for sepsis
The diagnostic performance of HemoSpec output to diagnose the presence of sepsis compared to the absence of sepsis. The diagnostic performance is composed by the aggregation of specificity, positive predictive value and negative predictive value.
Measured: 4 days
Prognostics performance for sepsis
The prognostic performance of HemoSpec output to predict unfavorable outcome compared to survivors. The prognostic performance is composed by the aggregation of sensitivity, specificity, positive predictive value and negative predictive value.
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 posted22 Nov 2017
- Study start2 Oct 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- General Hospital of Lamia, University of Jena
- Responsible party
- Principal investigator, Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens
- Investigators
- Evangelos J Giamarellos-Bourboulis, MD, PhD, Study chair, National and Kapodistrian University of AthensMagdalini Bristianou, MD, PhD, Principal investigator, General Hospital of LamiaMichael Bauer, MD, PhD, Principal investigator, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350113
- Sponsor's protocol ID
- INTELLIGENCE2
- Acronym
- INTELLIGENCE
- Status last verified
- May 2018
- First submitted
- 17 Nov 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Becker KL, Snider R, Nylen ES. Procalcitonin assay in systemic inflammation, infection, and sepsis: clinical utility and limitations. Crit Care Med. 2008 Mar;36(3):941-52. doi: 10.1097/CCM.0B013E318165BABB.
PubMed 18431284Giamarellos-Bourboulis EJ, Norrby-Teglund A, Mylona V, Savva A, Tsangaris I, Dimopoulou I, Mouktaroudi M, Raftogiannis M, Georgitsi M, Linner A, Adamis G, Antonopoulou A, Apostolidou E, Chrisofos M, Katsenos C, Koutelidakis I, Kotzampassi K, Koratzanis G, Koupetori M, Kritselis I, Lymberopoulou K, Mandragos K, Marioli A, Sunden-Cullberg J, Mega A, Prekates A, Routsi C, Gogos C, Treutiger CJ, Armaganidis A, Dimopoulos G. Risk assessment in sepsis: a new prognostication rule by APACHE II score and serum soluble urokinase plasminogen activator receptor. Crit Care. 2012 Aug 8;16(4):R149. doi: 10.1186/cc11463.
PubMed 22873681
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Clinical and Laboratory Information to Generate Technological Advance for the Diagnosis of Sepsis - The Intelligence 2 Trial
- ClinicalTrials.gov ID
- NCT03350113
- Acronym / sponsor ID
- INTELLIGENCE / INTELLIGENCE2
- Conditions
- Sepsis
- Keywords
- prognosis, diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Collaborators
- General Hospital of Lamia, University of Jena
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 22 Nov 2017 (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.
A diagnostic devise, namely HemoSpec, had been developed that integrates clinical information, along with information on circulating protein biomarkers and the morphology of white blood cells to achieve early diagnosis of sepsis. The current study is aiming to validate and improve performance of HemoSpec for the rapid assessment of the critically ill patient in the Emergency Department.
Detailed description
Sepsis is a life-threating organ dysfunction resulting from the dysregulated response of the host to an infection. It is estimated that 1.5 million people present with sepsis annually in Northern America and another 1.5 million people in Europe; 30 to 50% of them die making sepsis the leading cause of death. The key-point in the management of sepsis is the early resuscitation with broad- spectrum antimicrobials and intravenous fluids, if possible within the first hour. However, it is not easy to achieve this goal, especially among patients assessed in the Emergency Department (ED), as the diagnosis of an infection is often delayed until the patient's laboratory and imaging tests are completed.
In an attempt to improve the failure of physicians for early sepsis recognition in the ED, several markers have been developed. The most widely used biomarkers are the absolute number of neutrophils, C-reactive protein (CRP) and procalcitonin (PCT). HemoSpec is a device capable of incorporating clinical information from the patient with laboratory data. The analysis provides information on white blood cell morphology, CRP, PCT, interleukin (IL) -6 and suPAR. The device software has been created from all of the above information collected from prospective cohorts of patients from Greece and Germany. The diagnostic function of HemoSpec has so far been validated in two Phase II studies. The first study took place in Germany and involved 60 patients (20 controls, 20 with systemic inflammatory response and 20 with sepsis) who were hospitalized at the University Hospital in Jena. The second study is currently being conducted in Greece and aims to use the information from the HemoSpec device for the prospective categorization of patients with confirmed infection in patients with sepsis and in patients without sepsis.
The above two studies share a common Phase II design in order to validate HemoSpec's diagnostic ability among patients who are clinically diagnosed with sepsis. The clinical reliability of HemoSpec can be verified in a multicenter prospective trial involving patients assessed in the ED. The present study aims to assess the diagnostic ability of the device in ED patients with clinical signs of infection who have a significant risk of death that makes them likely to suffer from sepsis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HemoSpec | Experimental | Device: Blood sampling for analysisBlood Sampling for analysis in the HemoSpec device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission in the Emergency Department
- Age above or equal to 18 years old
- Both genders
- Written consent provided from patients or their first-degree relatives for patients unable to consent
- Considerable risk of death as indicated by the presence of at least one of the following: i) sudden alteration of mental status; ii) systolic blood pressure less than 100 mmHg; and iii) high respiratory rate defined as more than or equal to 22 breaths per minute.
Key exclusion criteria (5 listed)
- Known infection by the human immunodeficiency virus-1
- Acute myocardial infarction as evidenced by the electrocardiographic finding of ST- elevation.
- Single trauma or multiple injuries
- Known pregnancy and breastfeeding
- Patients with a life expectancy of less than 28 days and with limited treatment options
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 sampling for analysisAlso: HemospecBlood Sampling for Analysis | Device | HemoSpec |
Primary outcome
Sensitivity of HemoSpec for the diagnosis of sepsis
Time frame: 4 days
The sensitivity of HemoSpec output to diagnose the presence of sepsis compared to the absence of sepsis. HemoSpec output will be considered to provide a satisfactory diagnosis of sepsis if sensitivity for the diagnosis is greater than 90%.
2 secondary outcomes
Diagnostic performance for sepsis
Time frame: 4 days
Prognostics performance for sepsis
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Results publication: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Results publication: PubMed 18431284Becker KL, Snider R, Nylen ES. Procalcitonin assay in systemic inflammation, infection, and sepsis: clinical utility and limitations. Crit Care Med. 2008 Mar;36(3):941-52. doi: 10.1097/CCM.0B013E318165BABB.
- Results publication: PubMed 22873681Giamarellos-Bourboulis EJ, Norrby-Teglund A, Mylona V, Savva A, Tsangaris I, Dimopoulou I, Mouktaroudi M, Raftogiannis M, Georgitsi M, Linner A, Adamis G, Antonopoulou A, Apostolidou E, Chrisofos M, Katsenos C, Koutelidakis I, Kotzampassi K, Koratzanis G, Koupetori M, Kritselis I, Lymberopoulou K, Mandragos K, Marioli A, Sunden-Cullberg J, Mega A, Prekates A, Routsi C, Gogos C, Treutiger CJ, Armaganidis A, Dimopoulos G. Risk assessment in sepsis: a new prognostication rule by APACHE II score and serum soluble urokinase plasminogen activator receptor. Crit Care. 2012 Aug 8;16(4):R149. doi: 10.1186/cc11463.
- 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.
Evangelos J Giamarellos-Bourboulis, MD, PhD study chair
National and Kapodistrian University of Athens
Magdalini Bristianou, MD, PhD principal investigator
General Hospital of Lamia
Michael Bauer, MD, PhD principal investigator
Jena University Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling for analysis in people with Sepsis, run by University of Athens at 3 sites in 2 countries.
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 5 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: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece, Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity of HemoSpec for the diagnosis of sepsis (time frame: 4 days). 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 NCT03350113, which also lists 3 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 2 May 2018.