Evaluation of the Heparin Binding Protein Levels in Sepsis

Completed

Conditions studied: Sepsis, Infection, Septic Shock

In brief

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.

Key facts

Study ID

NCT02533011

Run by

Christiana Care Health Services

People needed

1055

Starts

2015-07-01

Expected to finish

2017-07-01

Last updated by the study team

2017-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of a bacterial or viral infection
• 18 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

Where it is running

• Christiana Care Health System — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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