Hemospec Device for Sepsis Diagnosis

NCT ID: NCT03350113

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2018-04-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

HemoSpec

Blood Sampling for analysis in the HemoSpec device

Group Type: EXPERIMENTAL

Blood sampling for analysis

Intervention Type: DEVICE

Blood Sampling for Analysis

Interventions

Blood sampling for analysis

Blood Sampling for Analysis

Intervention Type: DEVICE

Other Intervention Names

Hemospec

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Lamia

OTHER

Sponsor Role: collaborator

University of Jena

OTHER

Sponsor Role: collaborator

University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Evangelos J. Giamarellos-Bourboulis, M.D.

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evangelos J Giamarellos-Bourboulis, MD, PhD

Role: STUDY_CHAIR

National and Kapodistrian University of Athens

Magdalini Bristianou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Lamia

Michael Bauer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jena University Hospital

Locations

Univeristy of Jena

Jena, , Germany

General Hospital of Lamia

Lamia, Phthiotis, Greece

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, , Greece

Countries

Germany; Greece

References

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.

Reference Type: RESULT

PMID: 26903338 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18431284 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22873681 (View on PubMed)

Other Identifiers

INTELLIGENCE2

Identifier Type: -

Identifier Source: org_study_id