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OpenTrials
Completed

NCT Number: NCT03881566

Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients

This is an observational study to evaluate the diagnostic and prognostic value of presepsin in the critically-ill immunocompromise patients.

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Key information

Conditions

Sepsis Immune Deficiency Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female aged ≥ 19 years
  • Appropriate clinical data to enable classification into sepsis
  • Written informed consent by the patient or legally authorized representative
  • Critical illness consistent with sepsis, to be enrolled within 24 hours of presentation

Exclusion criteria

  • No informed consent
  • A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability

Treatment and study plan

Primary outcomes

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

    Time frame: up to 7 days

    For the analysis, plasma presepsin levels on Day 0 will be used. Sepsis was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between immunocompromised and immunocompetent patients is compared to that of procalcitonin.

Secondary outcomes

  1. survival at ICU discharge or day 28 after enrollment

    Time frame: 28 days

    For the analysis, we will evaluate the association between presepsin and survival at ICU discharge or day 28 after enrollment

Sponsors and collaborators

Lead sponsor

Jongmin Lee

Other

Registry information

Official study title

Study of Usefulness of Presepsin as Early Detective Marker of Sepsis in Immunodeficiency ICU Patients

Acronym: PREICU

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2019
Registry last updated
Apr 29, 2021

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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