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Completed

NCT Number: NCT02052895

Utility of Presepsin in Distinguishing Between Sepsis and SIRS

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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Key information

Conditions

SIRS Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lahey Clinic, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Sepsis/SIRS Patients

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

Exclusion criteria

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

Control

Inclusion criteria

  • 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

Exclusion criteria

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

End Stage Renal Disease

Inclusion criteria

  • 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%

Treatment and study plan

Primary outcomes

  1. Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between SIRS and Sepsis

    Time frame: Up to 7 days

    For the analysis, plasma presepsin levels on Day 0 were used and Sepsis/SIRS adjudication was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between SIRS and sepsis is compared to that of procalcitonin.

Sponsors and collaborators

Lead sponsor

Mochida Pharmaceutical Company, Ltd.

Industry

Registry information

Official study title

Utility of Presepsin in Distinguishing Between Sepsis and SIRS (Systemic Inflammatory Response Syndrome): an Exploratory, Prospective Observational Study in Critically Ill Patients

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2014
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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