Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients

NCT ID: NCT03881566

Last Updated: 2021-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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Conditions

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Sepsis Immune Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Patients without sepsis

Patients who admitted intensive care unit without sepsis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jongmin Lee

OTHER

Sponsor Role lead

Responsible Party

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Jongmin Lee

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jongmin Lee, M.D.

Role: STUDY_DIRECTOR

Seoul St. Mary's Hospital

Locations

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Seoul St. Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PRESEPSIN_IMMUNODIFFICIENCY

Identifier Type: -

Identifier Source: org_study_id

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