Primary Outcome Measures:
- Alveolar lavage concentrations of interleukin-8 (measured post-treatment at Days 2, 3, 6, 7, and 8)
Secondary Outcome Measures:
- Worst Murray Lung Injury Score
- Worst Multiple Organ Dysfunction (MOD) Score (Marshall) (measured at Days 1 through 7, and Day 28)
- Infections-nosocomial and/or surgical site infections
- Ventilator-free days
- Mortality (measured at Day 28)
BACKGROUND:
This study will use IC14, a recombinant chimeric monoclonal antibody (mAb) recognizing CD14, to block CD14 medicated cellular activation in patients with sepsis-induced ALI. Research results of antibody interaction with CD14 suggest that CD14 has a central role in the recognition of bacterial products and the induction of innate immune responses. Although beneficial, when this response is combined with a component of alveolar stretch it may induce an exaggerated response that can be harmful. This study will implement strategies to block CD14-mediated cellular activation and will evaluate whether this strategy has a beneficial effect in reducing alveolar inflammatory response, mechanical ventilation days, multiple organ failure, and severity of organ dysfunction in patients with sepsis-induced ALI.
DESIGN NARRATIVE:
The primary outcome of this study will be alveolar lavage concentrations of interleukin-8 that will be measured post-treatment at Days 2 and 3, and Days 6 to 8.
The key secondary outcomes of this study will be: 1) Worst Murray Lung Injury Score (measured at Days 1 through 7, and Day 28); 2) Worst Multiple Organ Dysfunction (MOD) Score (Marshall) (measured at Days 1 through 7, and Day 28); 3) Infections-nosocomial and/or surgical site infections (measured at Day 28); 4) Ventilator-free days (measured at Day 28); and 5) Mortality (measured at Day 28).