Evaluation of the Heparin Binding Protein Levels in Sepsis
NCT ID: NCT02533011
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1055 participants
OBSERVATIONAL
2015-07-31
2017-07-31
Brief Summary
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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.
Detailed Description
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Mechanisms that trigger the release of heparin-binding protein (HBP) from neutrophils in the presence of bacteria have previously been reported. HBP has several functions such as a chemo-attractant and as an activator of monocytes and macrophages. Also, it induces vascular leakage by interacting with the capillary endothelium and breaking cell barriers. In vivo studies have demonstrated that HBP released by the complex formed by the group A streptococcal M1 protein and fibrinogen induces a massive tissue edema contributing to severe organ damage. In clinical investigations, the release of HBP has been demonstrated in various infectious diseases caused by a wide array of bacteria. A recent single-center study of patients admitted for suspected infection and fever showed that plasma levels of HBP were significantly higher among patients who presented with or developed severe sepsis with circulatory failure.
A prospective observational study in a tertiary care Emergency Department. Patients must be identified and enrolled within 72 hours of qualifying inclusion criteria. At this time, unused blood samples collected for routine testing will be examined and the plasma level of HBP will be recorded; only blood samples processed by the lab within 3 hours of collection will be used. In addition, physiologic variables detailed in the data elements section, including mental status, metabolic, renal, heme, hepatic, respiratory, cardiovascular, resuscitation, and vasopressor use will be recorded. Patients who meet the inclusion criteria will be identified. Researchers will collect and record a resuscitation summary for a span of 4 hours; this data, outlined in the data elements section, will be linked to the quality improvement (QI) database of Sepsis Research. Additionally, the patient's HBP plasma levels will be measured from unused blood samples collected for routine lab testing time (T) 24, 48, and 72-hours (T24, T48, T72) after meeting the inclusion criteria (T0); resuscitation summaries will also be collected at T24, T48, T72. For patients meeting sepsis alert criteria, T0 will be defined as the time that the patient qualified; those enrolled based on Predisposition, Injury, Response, Organ dysfunction (PIRO) score will have T0 defined as the time hospital admission was ordered. Patients will be followed throughout their time in the hospital and their outcomes will be recorded.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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24 Hours
HBP lab test performed 24 hours after meeting sepsis inclusion criteria.
HBP lab test
Plasma level of Heparin Binding Protein will be evaluated on extra blood specimens already collected as part of standard of care.
48 Hours
HBP lab test performed 48 hours after meeting sepsis inclusion criteria.
HBP lab test
Plasma level of Heparin Binding Protein will be evaluated on extra blood specimens already collected as part of standard of care.
72 Hours
HBP lab test performed 72 hours after meeting sepsis inclusion criteria.
HBP lab test
Plasma level of Heparin Binding Protein will be evaluated on extra blood specimens already collected as part of standard of care.
Interventions
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HBP lab test
Plasma level of Heparin Binding Protein will be evaluated on extra blood specimens already collected as part of standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 .
Exclusion Criteria
* Patients who do not meet sepsis criteria as described above
18 Years
ALL
No
Sponsors
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Christiana Care Health Services
OTHER
Responsible Party
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Principal Investigators
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Ryan C. Arnold, MD
Role: PRINCIPAL_INVESTIGATOR
Christiana Care Health Services
Locations
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Christiana Care Health System
Newark, Delaware, United States
Countries
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References
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Murugan R, Karajala-Subramanyam V, Lee M, Yende S, Kong L, Carter M, Angus DC, Kellum JA; Genetic and Inflammatory Markers of Sepsis (GenIMS) Investigators. Acute kidney injury in non-severe pneumonia is associated with an increased immune response and lower survival. Kidney Int. 2010 Mar;77(6):527-35. doi: 10.1038/ki.2009.502. Epub 2009 Dec 23.
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Kjolvmark C, Akesson P, Linder A. Elevated urine levels of heparin-binding protein in children with urinary tract infection. Pediatr Nephrol. 2012 Aug;27(8):1301-8. doi: 10.1007/s00467-012-2132-x. Epub 2012 Mar 13.
Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.
Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.
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Other Identifiers
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602986
Identifier Type: -
Identifier Source: org_study_id