Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03881566
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jongmin Lee, Seoul St. Mary's Hospital

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
Sepsis Immune Deficiency

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Usefulness of Presepsin as Early Detective Marker of Sepsis in Immunodeficiency ICU Patients
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

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 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.



Primary Outcome Measures :
  1. Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between immunocompetent and immunocompromised patients. [ Time Frame: 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 :
  1. survival at ICU discharge or day 28 after enrollment [ Time Frame: 28 days ]
    For the analysis, we will evaluate the association between presepsin and survival at ICU discharge or day 28 after enrollment


Biospecimen Retention:   Samples Without DNA
Blood plasma, Blood serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with presentation to ICU with critical illness compatible with sepsis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881566


Contacts
Layout table for location contacts
Contact: Jongmin Lee, M.D. 82-10-6300-7128 dibs03@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Contact: Jongmin Lee, M.D.    82-10-6300-7128    dibs03@gmail.com   
Sponsors and Collaborators
Jongmin Lee
Investigators
Layout table for investigator information
Study Director: Jongmin Lee, M.D. Seoul St. Mary's Hospital

Layout table for additonal information
Responsible Party: Jongmin Lee, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT03881566     History of Changes
Other Study ID Numbers: PRESEPSIN_IMMUNODIFFICIENCY
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Sepsis
Toxemia
Immunologic Deficiency Syndromes
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Immune System Diseases