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NCT03881566 Clinical Trial

Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients

Sepsis Clinical Trial

— PREICU  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03881566
Other study ID # PRESEPSIN_IMMUNODIFFICIENCY
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date December 31, 2020

Study information
Verified date April 2021
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 119
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul St. Mary's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Jongmin Lee

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between immunocompetent and immunocompromised patients. 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. up to 7 days
Secondary survival at ICU discharge or day 28 after enrollment For the analysis, we will evaluate the association between presepsin and survival at ICU discharge or day 28 after enrollment 28 days
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