Hyporesponsiveness of Natural Killer Cells and a Dysfunct... | NCT02565589

Studies
Hyporesponsiveness of Natural Killer Cells and a Dysfunctional Inflammatory Response in Critically Ill Patients

NCT02565589

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Aug 4, 2017Actual

Enrollment

48Actual

Phase

Not provided

Conditions

Critical Illness

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Sep 30, 2015

First Submission Date that Met QC Criteria

Sep 30, 2015

First Posted Date

Oct 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 3, 2017

Last Update Posted Date

Aug 4, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICU patient		Critically ill patients who were enrolled less than 24 hours after ICU admission.
Control		Age-, sex-, and BMI-matched healthy subjects.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NK cell activity	NK cell activity (%)	Baseline

Secondary Outcomes

Measure	Description	Time Frame
IL (Interleukin)-12	IL-12 (pg/mL)	Baseline
hs-CRP (high-sensitivity C-reactive protein)	hs-CRP (mg/dL)	Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ICU patients
For healthy controls: nondiabetic and nonobese subjects

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29221433	Derived	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms