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Clinical Trials/NCT01135277
NCT01135277
Completed
Not Applicable

Immune Suppression and Ventilator Associated Pneumonias

Matthew Exline1 site in 1 country50 target enrollmentFebruary 1, 2010
ConditionsSepsis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sepsis
Sponsor
Matthew Exline
Enrollment
50
Locations
1
Primary Endpoint
Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients.
Status
Completed
Last Updated
7 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2010
End Date
November 1, 2012
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Matthew Exline
Responsible Party
Sponsor Investigator
Principal Investigator

Matthew Exline

Assistant Professor Clinical

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • ≥ 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).

Exclusion Criteria

  • Consent not available or declined
  • 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.

Outcomes

Primary Outcomes

Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients.

Time Frame: Day 5

Blood and BAL fluid will be collected at Day 5

Study Sites (1)

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