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NCT02565589 Clinical Trial

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

Critical Illness Clinical Trial

Official title:
Hyporesponsiveness of Natural Killer Cells and a Dysfunctional Inflammatory Response in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02565589
Other study ID # NK_ICU_healthy
Secondary ID
Status Completed
Phase N/A
First received September 30, 2015
Last updated August 3, 2017
Start date April 2014
Est. completion date September 2015

Study information
Verified date August 2017
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date September 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Outcome
Type Measure Description Time frame Safety issue
Primary NK cell activity NK cell activity (%) Baseline
Secondary IL (Interleukin)-12 IL-12 (pg/mL) Baseline
Secondary hs-CRP (high-sensitivity C-reactive protein) hs-CRP (mg/dL) Baseline
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