Hemospec Device for Sepsis Diagnosis (INTELLIGENCE)

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Device: Blood sampling for analysis

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Jena, Germany, 07743
    • Univeristy of Jena
• Greece
  • Athens, Greece, 12462
    • 4th Department of Internal Medicine, Attikon University Hospital
  • Phthiotis
    • Lamia, Phthiotis, Greece, 35100
      • General Hospital of Lamia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HemoSpec; Blood Sampling for analysis in the HemoSpec device	Device: Blood sampling for analysis; Blood Sampling for Analysis; Other Names: Hemospec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Athens
• Collaborators: University of Jena; General Hospital of Lamia
• Investigators: Principal Investigator: Magdalini Bristianou, MD, PhD, General Hospital of Lamia; Principal Investigator: Michael Bauer, MD, PhD, Jena University Hospital

Publications and helpful links

General 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.
• 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.
• Giamarellos-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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: November 17, 2017
• First Submitted That Met QC Criteria: November 17, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: prognosis; diagnosis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: INTELLIGENCE2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No