NCT03295825

Brief Summary

The primary objective of this study is to use heparin-binding protein (HBP) concentration to indicate the presence, or outcome, of sepsis over 72 hours after ED admission. The secondary objectives of this study are to separately evaluate the performance of HBP to predict outcome in patients with suspected infection over 12-24 hours after ED admission.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable sepsis

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable sepsis

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

September 22, 2017

Last Update Submit

October 20, 2018

Conditions

SepsisInfection

Keywords

Heparin binding proteinMortality

Outcome Measures

Primary Outcomes (1)

  • ΗΒΡ for sepsis diagnosis

    Sensitivity of ΗΒΡ for sepsis diagnosis. Every value over 90% is considered satisfactory.

    72 hours

Secondary Outcomes (4)

  • Diagnostic performance of HBP for sepsis

    72 hours

  • Diagnostic performance of HBP for septic shock

    72 hours

  • Diagnostic performance of HBP for early death

    72 hours

  • Diagnostic performance of HBP for death

    28 days

Study Arms (1)

Biomarker

OTHER

Blood sampling

Diagnostic Test: Biomarker

Interventions

BiomarkerDIAGNOSTIC_TEST

Measument of heparin-binding protein in the serum of patients

Also known as: Heparin Binding Protein
Biomarker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Male or female
  • Written informed consent
  • Suspected infection
  • Presence of at least ONE of the following:
  • Temperature \> 38°C Temperature \< 36°C Heart rate \> 90 bpm Respiratory rate \> 20/min Self reported fever/chills

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Nafplion General Hospital

Nafplion, Argos, 21100, Greece

Location

4th Department of Internal Medicine, ATTIKON University Hospital

Athens, Attica, 12462, Greece

Location

Department of Internal Medicine, Chalkida General Hospital

Chalcis, 34100, Greece

Location

Department of Internal Medicine, Siros General Hospital

Ermoupoli, 84100, Greece

Location

Department of Internal Medicine, Sparti General Hospital

Sparti, 23100, Greece

Location

2nd Department of Surgery, G.Gennimatas Thessaloniki General Hospital

Thessaloniki, 54635, Greece

Location

Related Publications (2)

  • Linder A, Christensson B, Herwald H, Bjorck L, Akesson P. Heparin-binding protein: an early marker of circulatory failure in sepsis. Clin Infect Dis. 2009 Oct 1;49(7):1044-50. doi: 10.1086/605563.

    PMID: 19725785BACKGROUND

  • Safarika A, Wacker JW, Katsaros K, Solomonidi N, Giannikopoulos G, Kotsaki A, Koutelidakis IM, Coyle SM, Cheng HK, Liesenfeld O, Sweeney TE, Giamarellos-Bourboulis EJ. A 29-mRNA host response test from blood accurately distinguishes bacterial and viral infections among emergency department patients. Intensive Care Med Exp. 2021 Jun 18;9(1):31. doi: 10.1186/s40635-021-00394-8.

    PMID: 34142256DERIVED

MeSH Terms

Conditions

SepsisInfections

Interventions

Environmental Biomarkers

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiomarkersBiological FactorsBiological PhenomenaEnvironmental MonitoringEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public Health

Study Officials

  • Evangelos Giamarellos-Bourboulis, MD, PhD

    National and Kapodistrian University of Athens

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2017

First Posted

September 28, 2017

Study Start

September 22, 2017

Primary Completion

June 30, 2018

Study Completion

September 30, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GR(6)