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OpenTrials
Completed

NCT Number: NCT01135277

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43221, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: Day 1

    Blood and BAL fluid will be collected at Day 1

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

    Time frame: Day 3

    Blood and BAL fluid will be collected at Day 3

  3. 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

Sponsors and collaborators

Lead sponsor

Matthew Exline

Other

Registry information

Acronym: iVAP

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2010
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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