Utility of Presepsin in Distinguishing Between Sepsis and SIRS

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-07-31

Brief Summary

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This is an observational study to evaluate the diagnostic accuracy of presepsin levels to discriminate between sepsis and SIRS upon presentation with critical illness compatible with either sepsis or systemic inflammatory response syndrome (SIRS).

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Detailed Description

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Conditions

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SIRS Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sepsis/SIRS

Patients with sepsis or SIRS

No interventions assigned to this group

Control

Patients without SIRS, sepsis, or end stage renal disease

No interventions assigned to this group

End Stage Renal Disease

Patients with end stage renal disease, without SIRS or sepsis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male or female aged ≥ 21 years
* Appropriate clinical data to enable classification into sepsis or SIRS
* Written informed consent by the patient or legally authorized representative
* Critical illness consistent with SIRS or sepsis, to be enrolled within 18 hours of presentation

* Male or female aged ≥ 21 years
* Does not meet clinical criteria for sepsis or SIRS
* Written informed consent by the patient or legally authorized representative

* Male or female aged ≥ 21 years
* Documented diagnosis of end stage renal disease currently undergoing dialysis
* Does not meet clinical criteria for sepsis or SIRS
* Written informed consent by the patient or legally authorized representative

Exclusion Criteria

* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

Control

* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

End Stage Renal Disease

* No informed consent
* Unacceptable risk imposed by extra blood sampling, such as by gross hemorrhage with a hematocrit \< 20%

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No