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Hemospec Device for the Diagnosis of Sepsis (INTELLIGENCE-1)

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ClinicalTrials.gov Identifier: NCT03306186
Recruitment Status : Completed
First Posted : October 10, 2017
Last Update Posted : May 15, 2018
Sponsor:
Collaborators:
Ippokration General Hospital
Tzanion General Hospital of Piraeus
Aghia Olga Konstantopouleion General Hospital
Information provided by (Responsible Party):
Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens

Tracking Information
First Submitted Date  ICMJE October 3, 2017
First Posted Date  ICMJE October 10, 2017
Last Update Posted Date May 15, 2018
Actual Study Start Date  ICMJE October 9, 2017
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
Sensitivity of HemoSpec for the diagnosis of sepsis [ Time Frame: 3 days ]
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%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2017)
  • Diagnostic performance for sepsis [ Time Frame: 3 days ]
    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.
  • Prognostics performance for sepsis [ Time Frame: 28 days ]
    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.
  • Prognostic performance for organ dysfunction [ Time Frame: 28 days ]
    The prognostic performance of HemoSpec output to predict progression into organ dysfunction. The prognostic performance is composed by the aggregation of sensitivity, specificity, positive predictive value and negative predictive value.
  • Diagnostic performance over qSOFA [ Time Frame: 3 days ]
    The aggregation of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of HemoSpec output to indicate patients with infection among those scoring positive for qSOFA.
  • Diagnostic performance and microbiology [ Time Frame: 3 days ]
    The diagnostic performance of HemoSpec output to diagnose the presence of sepsis between patients with microbiologically-proven infection and patients without microbiologically-proven infection. The diagnostic performance is composed by the aggregation of sensitivity, specificity, positive predictive value and negative predictive value.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemospec Device for the Diagnosis of Sepsis
Official Title  ICMJE Integration of Clinical and Laboratory Information to Generate Technological Advance for the Diagnosis of Sepsis
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.
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. The great mortality of sepsis indicates that this goal is not easy to be achieved for two main reasons: the first is the delay in recognition of the septic patients and the second is the resistance of the implicated pathogen to broad-spectrum antimicrobials.

In an attempt to improve the failure of physicians for early sepsis recognition, several markers have been developed. Some of them rely on clinical signs of the host and others on the measurements of circulating biomarkers. Recently, qSOFA (quick SOFA score) has been introduced to help the early recognition of sepsis in patients who present with infection outside the Intensive care Unit (ICU) i.e. either in the community or during hospitalization in the general ward1. However, there are concerns of the sensitivity of qSOFA and many introduce the need to measure biomarkers in serum. These biomarkers are usually protein molecules that are over-produced in the host as a result of the interaction with an infective insult. However, these protein molecules are produced by white blood cells. What is currently known is that although most of patients present with a similar phenotype, their pathophysiology is diverse. More precisely, although the majority of patients with sepsis present with high concentrations of protein molecules like interleukin (IL)-6, C-reactive protein (CRP) and procalcitonin (PCT) in their blood, in some patients circulating white blood cells remain over-active and in other patients they are significantly anergic, a situation often known as sepsis-induced immunoparalysis. Another molecule, called soluble urokinase plasminogen activator receptor (suPAR), is the shed uPAR receptor on neutrophils and is released in the circulation as a result of neutrophil activation; concentrations greater than 12 ng/ml can trace with negative predictive value almost 95% the patient at great chance of unfavorable outcome. As such, the robust diagnosis of sepsis may rely on a combination of clinical assessment, measurement of protein biomarkers and validation of the activity of circulating white blood cells.

One FrameWork 7-funded initiative from seven European countries aims to develop a rapid score that can integrate all clinical and laboratory information and provide early diagnosis whether a patient has sepsis or not. The vision of this initiative is to build a device that is called HemoSpec. With this approach, whole blood coming from patients will be in parallel analyzed into three aspects: a) absolute white blood cell counting; b) information on the fluidity and activity of the white blood cells using Raman spectroscopy; and c) measurement of serum levels of IL-6, CRP, PCT and suPAR. The end result is building a diagnostic algorithm where clinical information is also taken into consideration.

The project was started in November 2013 and the HemoSpec device is anticipated to be ready by February 2017. The diagnostic performance of HemoSpec is currently based on preliminary data coming from 60 patients (20 controls, 20 with systemic inflammatory response syndrome and 20 with sepsis) hospitalized in Jena University Hospital. The current study is aiming to validate and improve performance of HemoSpec for the rapid assessment of the critically ill patient in a larger phase II diagnostic study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Sepsis
Intervention  ICMJE Device: HemoSpec
Blood sampling for analysis
Study Arms  ICMJE Experimental: HemoSpec
Diagnosis of sepsis using HemoSpec device
Intervention: Device: HemoSpec
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 6, 2018)
183
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2017)
180
Actual Study Completion Date  ICMJE March 31, 2018
Actual Primary Completion Date December 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03306186
Other Study ID Numbers  ICMJE INTELLIGENCE1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Evangelos J. Giamarellos-Bourboulis, M.D., University of Athens
Study Sponsor  ICMJE University of Athens
Collaborators  ICMJE
  • Ippokration General Hospital
  • Tzanion General Hospital of Piraeus
  • Aghia Olga Konstantopouleion General Hospital
Investigators  ICMJE
Study Chair: Evangelos J Giamarellos-Bourboulis, MD, PhD National and Kapodistrian University of Athens
Principal Investigator: 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
PRS Account University of Athens
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP