Hemospec Device for the Diagnosis of Sepsis

NCT03306186 | Completed

• 1 other identifier: INTELLIGENCE1
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 5

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.

Conditions

Sepsis

Keywords

diagnosis; prognosis

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 85%.

  3 days

Secondary Outcomes (5)

• Diagnostic performance for sepsis

  3 days

• Prognostics performance for sepsis

  28 days

• Prognostic performance for organ dysfunction

  28 days

• Diagnostic performance over qSOFA

  3 days

• Diagnostic performance and microbiology

  3 days

Study Arms (1)

HemoSpec

EXPERIMENTAL

Diagnosis of sepsis using HemoSpec device

Device: HemoSpec

Interventions

HemoSpec DEVICE

Blood sampling for analysis

HemoSpec

Eligibility Criteria

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

You may qualify if:

• 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
• Patients with acute pancreatitis or post-operative or with clinical signs of infection
• Considerable risk of death as 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;
• Neutropenia defined as an absolute neutrophil count lower than 1000 neutrophils/mm3 due to reasons other than an infection.
• Single trauma or multiple injuries

Sponsors & Collaborators

• University of Athens: lead
• Ippokration General Hospital: collaborator
• Tzanion General Hospital of Piraeus: collaborator
• Aghia Olga Konstantopouleion General Hospital: collaborator

Study Sites (5)

1st Department of Propedeutic Surgery, Ippokration General Hospital

Athens, 11521, Greece

Location

Intensive Care Unit, Ippokration General Hospital

Athens, 11521, Greece

Location

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, 12462, Greece

Location

Intensive Care Unit, Aghia Olga Konstantopouleion General Hospital

Athens, 14232, Greece

Location

Intensive Care Unit, Tzanio Hospital of Piraeus

Piraeus, 18536, 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sepsis; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Evangelos J Giamarellos-Bourboulis, MD, PhD

  National and Kapodistrian University of Athens

  STUDY CHAIR

• Konstantinos Toutouzas, MD, PhD

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

• Athanasios Prekates, MD, PhD

  Tzaneion General Hospital

  PRINCIPAL INVESTIGATOR

• Stylianos Karatzas, MD, PhD

  Ippokration General Hospital

  PRINCIPAL INVESTIGATOR

• Christos Mathas, MD

  Aghia Olga General 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: October 3, 2017
• First Posted: October 10, 2017
• Study Start: October 9, 2017
• Primary Completion: December 30, 2017
• Study Completion: March 31, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (5)