Hemospec Device for Sepsis Diagnosis

NCT03350113 | Completed

• 1 other identifier: INTELLIGENCE2
• Study Type: interventional
• Target: 129
• Locations: 2 countries
• Sites: 3

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.

Conditions

Sepsis

Keywords

prognosis; diagnosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Diagnostic performance for sepsis

  4 days

• Prognostics performance for sepsis

  28 days

Study Arms (1)

HemoSpec

EXPERIMENTAL

Blood Sampling for analysis in the HemoSpec device

Device: Blood sampling for analysis

Interventions

Blood sampling for analysis DEVICE

Blood Sampling for Analysis

Also known as: Hemospec

HemoSpec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Athens: lead
• General Hospital of Lamia: collaborator
• University of Jena: collaborator

Study Sites (3)

Univeristy of Jena

Jena, 07743, Germany

Location

General Hospital of Lamia

Lamia, Phthiotis, 35100, Greece

Location

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, 12462, Greece

Location

Related Publications (3)

• 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.

  PMID: 26903338 RESULT

• 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.

  PMID: 18431284 RESULT

• 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.

  PMID: 22873681 RESULT

MeSH Terms

Conditions

Sepsis; Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Evangelos J Giamarellos-Bourboulis, MD, PhD

  National and Kapodistrian University of Athens

  STUDY CHAIR

• Magdalini Bristianou, MD, PhD

  General Hospital of Lamia

  PRINCIPAL INVESTIGATOR

• Michael Bauer, MD, PhD

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 22, 2017
• Study Start: October 2, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (2); DE (1)