SepsisPREICUNCT03881566
Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients
An observational study of Sepsis and Immune Deficiency, run by Jongmin Lee at 1 site in South Korea.
Trial summary
This is an observational study to evaluate the diagnostic and prognostic value of presepsin in the critically-ill immunocompromise patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Sepsis, Immune Deficiency
- How many people
- 119 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2019to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with presentation to ICU with critical illness compatible with sepsis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sepsis, Immune Deficiency
- Medical subject headings
- Sepsis, Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days
Secondary outcomes (1)
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jongmin Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jongmin Lee, Seoul St. Mary's Hospital
- Investigators
- Jongmin Lee, M.D., Study director, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881566
- Sponsor's protocol ID
- PRESEPSIN_IMMUNODIFFICIENCY
- Acronym
- PREICU
- Status last verified
- Apr 2021
- First submitted
- 9 Mar 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Usefulness of Presepsin as Early Detective Marker of Sepsis in Immunodeficiency ICU Patients
- ClinicalTrials.gov ID
- NCT03881566
- Acronym / sponsor ID
- PREICU / PRESEPSIN_IMMUNODIFFICIENCY
- Conditions
- Sepsis, Immune Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Jongmin LeeUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study to evaluate the diagnostic and prognostic value of presepsin in the critically-ill immunocompromise patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with presentation to ICU with critical illness compatible with sepsis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
survival at ICU discharge or day 28 after enrollment
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jongmin Lee, M.D. study director
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Immune Deficiency, run by Jongmin Lee at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.