PREICU: Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients

Sponsor

Jongmin Lee (Other)

Overall Status

Completed

CT.gov ID

NCT03881566

Collaborator

(none)

119

Enrollment

Location

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sepsis Immune Deficiency

Study Design

Study Type:

Observational

Actual Enrollment :

119 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St. Mary's Hospital	Seoul		Korea, Republic of	06591

Sponsors and Collaborators

Jongmin Lee

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jongmin Lee, Professor, Seoul St. Mary's Hospital

ClinicalTrials.gov Identifier:

NCT03881566

Other Study ID Numbers:

PRESEPSIN_IMMUNODIFFICIENCY

First Posted:

Mar 19, 2019

Last Update Posted:

Apr 29, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sepsis

Toxemia

Immunologic Deficiency Syndromes

Study Results

No Results Posted as of Apr 29, 2021