Immune Suppression and Ventilator Associated Pneumonias

NCT01135277 | Completed

• 1 other identifier: 2009H0165
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (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 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• ≥ 18 years.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Matthew Exline: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood Bronchoalveolar lavage fluid

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew Exline, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor Clinical

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: June 2, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (1)