Evaluation of the Heparin Binding Protein Levels in Sepsis

NCT02533011 | Completed

• 1 other identifier: 602986
• Study Type: observational
• Target: 1,055
• Locations: 1 country
• Sites: 1

Brief Summary

Present criteria used to define sepsis are non-specific, making it difficult to both distinguish sepsis from other diseases and to predict which patients are likely to become more severely ill. In standard care, patients at risk of becoming more severely ill are neither identified nor indicated for resuscitative efforts until they develop hemodynamic insufficiency or organ failure; after progression to severe disease, mortality increases significantly. The identification of risk patients can lead to earlier initiation of resuscitation therapies and potentially lead to reduced morbidity and mortality. This study aims to determine whether Heparin-binding protein (HBP), which is secreted from neutrophils during infection and a mediator of vascular leakage, can act as a biomarker for the progression to severe sepsis with circulatory failure. The objective of this study is to validate the utility of HBP to predict the development of delayed onset organ dysfunction in sepsis in patients and to compare the performance of HBP relative to currently used prognostic biomarkers in sepsis.

Conditions

Sepsis; Infection; Septic Shock

Keywords

Sepsis; Heparin Binding Protein

Outcome Measures

Primary Outcomes (1)

• Infection with organ dysfunction, defined as PIRO (Predisposition, Insult, Response, Organ Dysfunction) Score greater than 5

  Patients with septic shock or severe sepsis

  72 hours after meeting sepsis criteria

Study Arms (3)

24 Hours

HBP lab test performed 24 hours after meeting sepsis inclusion criteria.

Other: HBP lab test

48 Hours

HBP lab test performed 48 hours after meeting sepsis inclusion criteria.

Other: HBP lab test

72 Hours

HBP lab test performed 72 hours after meeting sepsis inclusion criteria.

Other: HBP lab test

Interventions

HBP lab test OTHER

Plasma level of Heparin Binding Protein will be evaluated on extra blood specimens already collected as part of standard of care.

Also known as: Plasma level of heparin binding protein

24 Hours; 48 Hours; 72 Hours

Eligibility Criteria

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

Study Population

Patients admitted through the emergency department with infection.

You may qualify if:

• Clinical diagnosis of a bacterial or viral infection
• years or older
• Meet the sepsis alert criterion (Hypotension (BP \< 90 after 2 L of fluids or lactate ≥ 4) OR
• PIRO (Predispose, Infection, Response, Organ dysfunction ) score ≥ 15 .

You may not qualify if:

• Minors (less than 18 years of age)
• Patients who do not meet sepsis criteria as described above

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Sepsis; Infections; Shock, Septic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ryan C. Arnold, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: August 26, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: July 1, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

US (1)