Immune Suppression and Ventilator Associated Pneumonias

Sepsis Clinical Trial

— iVAP  

Official title:

Immune Suppression and Ventilator Associated Pneumonias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135277
• Other study ID #: 2009H0165
• Status: Completed
• Phase: N/A
• First received: May 26, 2010
• Last updated: April 8, 2016
• Start date: February 2010
• Est. completion date: November 2012

Study information

• Verified date: April 2016
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated
• Sepsis

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Matthew Exline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No