Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Heparin Binding Protein in Early Sepsis Diagnosis (PROMPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03295825
Recruitment Status : Completed
First Posted : September 28, 2017
Last Update Posted : October 23, 2018
Sponsor:
Collaborators:
National and Kapodistrian University of Athens
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
Hellenic Institute for the Study of Sepsis

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.

Condition or disease Intervention/treatment Phase
Sepsis Infection Diagnostic Test: Biomarker Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Indicate the Presence and Outcome of Sepsis in Patients With Suspected Infection Following Emergency Department Admission
Actual Study Start Date : September 22, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Biomarker
Blood sampling
Diagnostic Test: Biomarker
Measument of heparin-binding protein in the serum of patients
Other Name: Heparin Binding Protein




Primary Outcome Measures :
  1. ΗΒΡ for sepsis diagnosis [ Time Frame: 72 hours ]
    Sensitivity of ΗΒΡ for sepsis diagnosis. Every value over 90% is considered satisfactory.


Secondary Outcome Measures :
  1. Diagnostic performance of HBP for sepsis [ Time Frame: 72 hours ]
    Specificity, positive predictive value and negative predictive value of HBP to diagnose sepsis

  2. Diagnostic performance of HBP for septic shock [ Time Frame: 72 hours ]
    Specificity, positive predictive value and negative predictive value of HBP to diagnose septic shock

  3. Diagnostic performance of HBP for early death [ Time Frame: 72 hours ]
    Sensitivity, specificity, positive predictive value and negative predictive value of HBP to predict unfavorable outcome

  4. Diagnostic performance of HBP for death [ Time Frame: 28 days ]
    Sensitivity, specificity, positive predictive value and negative predictive value of HBP to predict unfavorable outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295825


Locations
Layout table for location information
Greece
Nafplion General Hospital
Náfplio, Argos, Greece, 21100
4th Department of Internal Medicine, ATTIKON University Hospital
Athens, Attiki, Greece, 12462
Department of Internal Medicine, Chalkida General Hospital
Chalkida, Greece, 34100
Department of Internal Medicine, Siros General Hospital
Ermoupolis, Greece, 84100
Department of Internal Medicine, Sparti General Hospital
Sparti, Greece, 23100
2nd Department of Surgery, G.Gennimatas Thessaloniki General Hospital
Thessaloníki, Greece, 54635
Sponsors and Collaborators
Hellenic Institute for the Study of Sepsis
National and Kapodistrian University of Athens
Aristotle University Of Thessaloniki
Investigators
Layout table for investigator information
Study Chair: Evangelos Giamarellos-Bourboulis, MD, PhD National and Kapodistrian University of Athens
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hellenic Institute for the Study of Sepsis
ClinicalTrials.gov Identifier: NCT03295825    
Other Study ID Numbers: PROMPT
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hellenic Institute for the Study of Sepsis:
Heparin binding protein
Mortality
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action