Immune Suppression and Ventilator Associated Pneumonias (iVAP)

Patients in the ICU are already predisposed to nosocomial infections, which are both costly and potentially life threatening, and it appears that the immune paralysis of sepsis may put these patients at greater risk for secondary infections, though this has not been proven conclusively. One measure of this sepsis-induced immune suppression is monocyte deactivation. The investigators hypothesize that, as a cornerstone of the monocytic innate immune response to infection, the inflammasome is critical to monocyte function during sepsis.

Study Overview

• Status: Completed
• Conditions: Sepsis

Detailed Description

Sepsis is a systemic inflammatory response to a severe infection. Despite the high incidence and societal costs of sepsis, the mechanism by which it kills remains unclear. The pathophysiology of sepsis is not completely understood, but many investigators now believe that sepsis induces a prolonged state of immune suppression. This study will attempt to quantify the degree of immune suppression during the first 5 days of sepsis by measuring the immune function of peripheral blood monocytes and the inflammasome constituent proteins in peripheral blood monocytes and alveolar macrophages.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will be open to males and females, 18 years or older, who spend at least one day on mechanic ventilation in the Ohio State University Medical Intensive Care Unit

Description

Inclusion Criteria:

1. ≥ 18 years.

2. Have consensus criteria for sepsis (infection plus two of four systemic inflammatory response syndrome [SIRS] signs [tachycardia, tachypnea, fever or hypothermia, leukocytosis or leukopenia]) and a known or suspected infection for SEPTIC arm.

   • Patients without criteria for sepsis will be eligible for CONTROL arm. Patient must consent to have blood drawn within 24 hours of initiation of mechanical ventilation (for CONTROL arm) and 24 hours of new episode of sepsis to be eligible (for SEPTIC arm).

Exclusion Criteria:

1. Consent not available or declined
2. Prisoner
3. Died before blood collected
4. Onset of sepsis more than 24 hours prior to transfer to OSUMC,mechanical ventilation greater than 24 hours
5. Anticipation of less than 24 hours of mechanical ventilation by primary team
6. Women who are pregnant.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sepsis; Patients who have been diagnosed with Sepsis within 24 hours of admission
Non-Septic; Patients who have not been diagnosed with sepsis within 24 hours of admission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients.	Blood and BAL fluid will be collected at Day 1	Day 1
Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients.	Blood and BAL fluid will be collected at Day 3	Day 3
Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients.	Blood and BAL fluid will be collected at Day 5	Day 5

Collaborators and Investigators

• Sponsor: Matthew Exline
• Investigators: Principal Investigator: Matthew Exline, M.D., Ohio State University

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: June 1, 2010
• First Posted (Estimated): June 2, 2010

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis
• Other Study ID Numbers: 2009H0165