Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients (PREICU)

Study of Usefulness of Presepsin as Early 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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Immune Deficiency

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06591
    • Seoul St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with presentation to ICU with critical illness compatible with sepsis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Immunocompetent sepsis patients; Sepsis patients without HIV infection (all stages), neutropenia (neutrophil count < 1 × 109/L), exposure to glucocorticoids (> 0.5 mg/kg for > 30 d) and/or immunosuppressive or cytotoxic medications, solid organ transplantation, allogeneic or autologous stem cell transplantation, hematological malignancy, or solid tumor.
Immunocompromised sepsis patients; Sepsis patients with HIV infection (all stages), neutropenia (neutrophil count < 1 × 109/L), exposure to glucocorticoids (> 0.5 mg/kg for > 30 d) and/or immunosuppressive or cytotoxic medications, solid organ transplantation, allogeneic or autologous stem cell transplantation, hematological malignancy, or solid tumor.
Patients without sepsis; Patients who admitted intensive care unit without sepsis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jongmin Lee
• Investigators: Study Director: Jongmin Lee, M.D., Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 9, 2019
• First Submitted That Met QC Criteria: March 16, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 28, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Immune System Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Immunologic Deficiency Syndromes
• Other Study ID Numbers: PRESEPSIN_IMMUNODIFFICIENCY

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No