Critical IllnessNCT02565589
Hyporesponsiveness of Natural Killer Cells and a Dysfunctional Inflammatory Response in Critically Ill Patients
An observational study of Critical Illness, run by Yonsei University.
Trial summary
To investigate natural killer (NK) cell activities, circulating cytokine levels and peripheral blood mononuclear cell (PBMC) cytokine production status in critically ill patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Sep 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: From April 2014 to July 2015, 24 critically ill patients were enrolled in this study after admission to the ICU at Yonsei University Severance Hospital. For validation of the experimental findings, age-, sex- and BMI-matched healthy subjects were enrolled as controls among individuals seen at a health evaluation center during the same period.
Who may be able to join
- ICU patients
- For healthy controls: nondiabetic and nonobese subjects
Who cannot join
- For healthy controls: diabetes; history/presence of significant metabolic disease; pregnancy or breast-feeding; acute or chronic infection; liver disease; kidney disease; gastrointestinal disease; subjects taking any drugs or supplements
About this study
To investigate natural killer (NK) cell activities, circulating cytokine levels and peripheral blood mononuclear cell (PBMC) cytokine production status in critically ill patients.
Read the detailed description
Blood samples were collected < 24 hours after admission from 24 intensive care unit (ICU) patients and 24 age-, sex-, and body mass index (BMI)-matched healthy controls. NK cell activities, cytokine concentrations and cytokine production by PBMCs and lipopolysaccharide (LPS)-stimulated PBMCs were measured.
- Conditions
- Critical Illness
- Medical subject headings
- Critical Illness
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 |
|---|---|---|
| ICU patient | Critically ill patients who were enrolled less than 24 hours after ICU admission. | |
| Control | Age-, sex-, and BMI-matched healthy subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NK cell activity
NK cell activity (%)
Measured: Baseline
Secondary outcomes (2)
IL (Interleukin)-12
IL-12 (pg/mL)
Measured: Baseline
hs-CRP (high-sensitivity C-reactive protein)
hs-CRP (mg/dL)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startApr 2014
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565589
- Sponsor's protocol ID
- NK_ICU_healthy
- Status last verified
- Aug 2017
- First submitted
- 30 Sep 2015
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim M, Kim M, Jeong H, Chae JS, Kim YS, Lee JG, Cho Y, Lee JH. Hyporesponsiveness of natural killer cells and impaired inflammatory responses in critically ill patients. BMC Immunol. 2017 Dec 8;18(1):48. doi: 10.1186/s12865-017-0231-y.
PubMed 29221433
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyporesponsiveness of Natural Killer Cells and a Dysfunctional Inflammatory Response in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02565589
- Acronym / sponsor ID
- NK_ICU_healthy
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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.
To investigate natural killer (NK) cell activities, circulating cytokine levels and peripheral blood mononuclear cell (PBMC) cytokine production status in critically ill patients.
Detailed description
Blood samples were collected < 24 hours after admission from 24 intensive care unit (ICU) patients and 24 age-, sex-, and body mass index (BMI)-matched healthy controls. NK cell activities, cytokine concentrations and cytokine production by PBMCs and lipopolysaccharide (LPS)-stimulated PBMCs were measured.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU patient | – | –Critically ill patients who were enrolled less than 24 hours after ICU admission. |
| Control | – | –Age-, sex-, and BMI-matched healthy subjects. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From April 2014 to July 2015, 24 critically ill patients were enrolled in this study after admission to the ICU at Yonsei University Severance Hospital. For validation of the experimental findings, age-, sex- and BMI-matched healthy subjects were enrolled as controls among individuals seen at a health evaluation center during the same period.
Key inclusion criteria (2 listed)
- ICU patients
- For healthy controls: nondiabetic and nonobese subjects
Key exclusion criteria (1 listed)
- For healthy controls: diabetes; history/presence of significant metabolic disease; pregnancy or breast-feeding; acute or chronic infection; liver disease; kidney disease; gastrointestinal disease; subjects taking any drugs or supplements
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
NK cell activity
Time frame: Baseline
NK cell activity (%)
2 secondary outcomes
IL (Interleukin)-12
Time frame: Baseline
hs-CRP (high-sensitivity C-reactive protein)
Time frame: Baseline
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 4 Aug 2017.
- Derived from this study: PubMed 29221433Kim M, Kim M, Jeong H, Chae JS, Kim YS, Lee JG, Cho Y, Lee JH. Hyporesponsiveness of natural killer cells and impaired inflammatory responses in critically ill patients. BMC Immunol. 2017 Dec 8;18(1):48. doi: 10.1186/s12865-017-0231-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Yonsei University.
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 2 inclusion and 1 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 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
NK cell activity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565589, which also lists 1 linked publication.
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 4 Aug 2017.