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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Immune Deficiency
• Immunologic Deficiency Syndromes
• Sepsis
• Toxemia

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