Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients

NCT03881566 | Completed

• 1 other identifier: PRESEPSIN_IMMUNODIFFICIENCY
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis; Immune Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• survival at ICU discharge or day 28 after enrollment

  28 days

Study Arms (3)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jongmin Lee: lead

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma, Blood serum

MeSH Terms

Conditions

Sepsis; Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Jongmin Lee, M.D.

  Seoul St. Mary's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 19, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

KR (1)