Platelet Immune Responses in Aging and Influenza and Sepsis (INVACS)



Status:Enrolling by invitation
Conditions:Influenza, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:12/2/2018
Start Date:December 2014
End Date:July 2019

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Aging is associated with immunosenescence and impaired host defense mechanisms, contributing
to influenza-related morbidity and mortality. Preliminary data demonstrate that the platelet
transcriptome is markedly different between healthy subjects and influenza patients.
Interferon-induced transmembrane proteins (IFITM) family members are among the transcripts
significantly increased in platelets during influenza and expression of IFITM-3 is impaired
in elderly subjects, a pattern associated with increased mortality. This study will build on
these data and investigate if aging influences the expression of platelet IFITM family
members in patients with influenza and sepsis.

This study will prospectively determine if aging alters the induction of (IFITMs) in
platelets from hospitalized influenza and sepsis patients. The study will also determine if
diminished expression of IFITM family members correlates with an increased risk of adverse
outcomes in older influenza and sepsis patients.

This will be a prospective observational cohort study comparing older (age≥65) and younger
(age<65) influenza and sepsis patients.

Inclusion Criteria:

- ≥18 years old at the time of enrollment

- Meet one of the following three main criteria:

A. INFLUENZA (AND OTHER RESPIRATORY VIRUS) PATIENTS:

Patients admitted to the intensive care unit (ICU) with a primary microbiologic diagnosis
of influenza (any strain) or other routinely clinically identified respiratory viruses
within 1 week of symptom onset. Influenza or other respiratory virus will be diagnosed
using an RT-PCR viral panel on a respiratory tract specimen, as is currently standard of
care on patients admitted to the ICUs at IMC with respiratory symptoms.

OR

B. SEPSIS PATIENTS:

Sepsis patients must have

1. Suspected or confirmed infection

AND

2. Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data
available, SOFA assumed to be 0)

OR

C. SEPTIC SHOCK PATIENTS:

AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, Septic shock patients must have

1. Suspected or confirmed infection

AND

2. Lactate > 2 mmol/L

AND

3. Receiving vasopressors

- All patients must be enrolled into the study within 72 hours of ICU admission

Exclusion criteria

- Have a congenital or acquired immunodeficiency disorder (e.g., chronic variable immune
deficiency, agammaglobulinemia, hypogammaglobulinemia, leukocyte adhesion defects, IgA
deficiency, etc.)

- Have neutropenia (<1,000/mm3)

- Have received immunosuppressant medications within the previous 30 days (e.g.,
prednisone or prednisone equivalent at a dose≥10mg daily for ≥14 days or any
cyclosporine, TNF-alpha antagonists, tacrolimus, sirolimus, interferons,
mycophenolate, biological agents, methotrexate, azathioprine, polyclonal/monoclonal
antibodies, etc.)

- Have any history of bone marrow or organ transplantation

- Have an active malignancy (not including non-melanoma skin cancer or localized
prostate cancer), or have received chemotherapy drugs within the last 6 months.

- Have been admitted to the ICU for greater than 72 hours

- Have a Hemoglobin level <7gm/dl

- Have clinically significant bleeding
We found this trial at
1
site
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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