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

NCT ID: NCT03010410

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-21
• Study Completion Date: 2019-12-31

Brief Summary

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.

Detailed Description

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

Conditions

Sepsis; Influenza

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Influenza/respiratory virus pts <65 yrs

Patients with a primary microbiologic diagnosis of influenza (any strain) or other routinely clinically identified respiratory viruses

No interventions assigned to this group

Influenza/respiratory virus pts ≥ 65 yrs

Patients with a primary microbiologic diagnosis of influenza (any strain) or other routinely clinically identified respiratory viruses

No interventions assigned to this group

Sepsis/septic shock patients < 65 yrs

Sepsis and septic shock patients

No interventions assigned to this group

Sepsis/septic shock patients ≥ 65 yrs

sepsis and septic shock patients

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Samuel Brown

Director, Center for Humanizing Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel M Brown, MD MS

Role: PRINCIPAL_INVESTIGATOR

Intermountain Health Care, Inc.

Locations

Intermountain Medical Center

Murray, Utah, United States

Countries

United States

Other Identifiers

1040298

Identifier Type: -

Identifier Source: org_study_id