Immune Suppression and Ventilator Associated Pneumonias (iVAP)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Matthew Exline, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01135277
First received: May 26, 2010
Last updated: November 6, 2012
Last verified: November 2012

May 26, 2010
November 6, 2012
February 2010
December 2012   (final data collection date for primary outcome measure)
  • Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Blood and BAL fluid will be collected at Day 1
  • Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients. [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    Blood and BAL fluid will be collected at Day 3
  • Immune suppression during the recovery from critical illness is greater in severe sepsis patients compared to non-septic patients. [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    Blood and BAL fluid will be collected at Day 5
Same as current
Complete list of historical versions of study NCT01135277 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Immune Suppression and Ventilator Associated Pneumonias
Immune Suppression and Ventilator Associated Pneumonias

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Peripheral blood Bronchoalveolar lavage fluid

Non-Probability Sample

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

Sepsis
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
May 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01135277
2009H0165
No
Matthew Exline, The Ohio State University
Matthew Exline
Not Provided
Principal Investigator: Matthew Exline, M.D. Ohio State University
Ohio State University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP