NCT02565589

Brief Summary

To investigate natural killer (NK) cell activities, circulating cytokine levels and peripheral blood mononuclear cell (PBMC) cytokine production status in critically ill patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

September 30, 2015

Last Update Submit

August 3, 2017

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • NK cell activity

    NK cell activity (%)

    Baseline

Secondary Outcomes (2)

  • IL (Interleukin)-12

    Baseline

  • hs-CRP (high-sensitivity C-reactive protein)

    Baseline

Study Arms (2)

ICU patient

Critically ill patients who were enrolled less than 24 hours after ICU admission.

Control

Age-, sex-, and BMI-matched healthy subjects.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • ICU patients
  • For healthy controls: nondiabetic and nonobese subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29221433DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 1, 2015

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

August 4, 2017

Record last verified: 2017-08