An interventional study of Blood sampling for analysis in Sepsis, sponsored by University of Athens. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-02.
Sponsored by University of Athens · Not applicable, Interventional, and Diagnostic
Among 44 studies in Sepsis with a site in Greece — 9 open to participants now, 11 under way, 4 of them phase 3. Sepsis · Greece.
Among the 44 studies in Sepsis with a site in Greece, this one is the 19th largest by enrollment of the 26 interventional ones, is one of 8 that started in 2017, is one of 6 with no phase, and was the 20th registered.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 129 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →9 of the 44 studies in Sepsis with a site in Greece are open now, in 12 countries. Each count lists the studies.
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →44 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 8 started in 2017.
Median enrollment 210 across the 26 interventional studies, 200 across the 17 observational. Of the 28 that completed or were terminated, 5 (18%) have results posted.
9 of 44 have an industry lead sponsor. The 10 most frequent:
University of Athens is the lead sponsor of 139 studies on the registry; 19 are open to participants now.
University of Athens has 7 studies filed under Sepsis — fewer than ten, so there is no comparison to draw.
3 of the studies in Sepsis with a site in Greece that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06694701Hellenic Institute for the Study of SepsisEmapalumab Treatment For Anticipated Clinical Benefit In Sepsis Driven By The Interferon-Gamma Endotype (The EMBRACE Trial) | 2026-11 |
| NCT07215702AstraZenecaA Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury. | 2027-02-11 |
| NCT07927621Hellenic Institute for the Study of SepsisViscoelastic Coagulation Monitoring for Early Identification of Sepsis: The VISION II Study | 2027-05 |
Among the 44 studies in Sepsis with a site in Greece, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood Sampling for analysis in the HemoSpec device
Device: Blood sampling for analysis
Blood Sampling for Analysis
Also known as: Hemospec
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%.
Time frame: 4 days
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.
Time frame: 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.
Time frame: 28 days
Plan to share: No
Ran from Oct 2017 to primary completion in Apr 2018, 6 months.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 6 months is below that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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