Hemospec Device for Sepsis Diagnosis

Sepsis Clinical Trial

— INTELLIGENCE  

Official title:

Integration of Clinical and Laboratory Information to Generate Technological Advance for the Diagnosis of Sepsis - The Intelligence 2 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350113
• Other study ID #: INTELLIGENCE2
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2018
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Device:
• Blood sampling for analysis
Blood Sampling for Analysis

Locations

Country	Name	City	State
Germany	Univeristy of Jena	Jena
Greece	4th Department of Internal Medicine, ATTIKON University Hospital	Athens
Greece	General Hospital of Lamia	Lamia	Phthiotis

Sponsors (3)

Lead Sponsor	Collaborator
University of Athens	Lamia General Hospital, University of Jena

Countries where clinical trial is conducted

Germany,  Greece, 

References & Publications (3)

Becker 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. Review. — View Citation

Giamarellos-Bourboulis EJ, Norrby-Teglund A, Mylona V, Savva A, Tsangaris I, Dimopoulou I, Mouktaroudi M, Raftogiannis M, Georgitsi M, Linnér A, Adamis G, Antonopoulou A, Apostolidou E, Chrisofos M, Katsenos C, Koutelidakis I, Kotzampassi K, Koratzanis G, — View Citation

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 C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	4 days
Secondary	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.	4 days
Secondary	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.	28 days