Validation of Prognostic Club Cell Secretory Protein (CC16) Cut-point in an Independent ALTA Cohort

Author:

Almuntashiri Sultan12,Chase Aaron34,Sikora Andrea34,Zhang Duo15ORCID

Affiliation:

1. Clinical and Experimental Therapeutics, College of Pharmacy, University of Georgia and Charlie Norwood VA Medical Center, Augusta, GA, USA

2. Department of Clinical Pharmacy, College of Pharmacy, University of Hail, Hail, Saudi Arabia

3. Department of Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia, Augusta, GA, USA

4. Department of Pharmacy, Augusta University Medical Center, Augusta, GA, USA

5. Department of Medicine, Augusta University, Augusta, GA, USA

Abstract

Background: Club cell secretory protein (CC16) has demonstrated utility as a lung-specific biomarker in predicting mortality in acute respiratory distress syndrome (ARDS). These findings have been observed in pre-clinical trials and a re-analysis of a large, randomized controlled trial of ARDS (Fluid and Catheter Treatment Trial (FACTT)). Objectives: The purpose of this study was to validate previous findings by evaluating CC16 level as a mortality predictor in patients from the albuterol to treat acute lung injury (ALTA) trial. Design and Method: In this secondary biomarker analysis, plasma CC16 level was measured from 100 ALTA subjects using enzyme-linked immunosorbent assay (ELISA). The rate of mortality was assessed in patients with high (⩾45 ng/mL) versus low CC16 (<45 ng/mL) levels. This cut-off level was applied based on our previous analysis from FACTT trial. Significance was assessed using Kaplan-Meier curves and a log-rank test. Results: Subjects were an average of 50 years old and 46% of them were females. Patients with high CC16 levels had higher 90-day mortality compared to those with low CC16 levels, (37.73% vs 8.95%, P < .001). Other clinical outcomes including ICU-free days, ventilator-free days, and organ failure free days were significantly different between the groups (All P < .05). Conclusion: In this validation study, we demonstrated that ARDS patients with high plasma CC16 concentration had a higher mortality rate than those with low CC16 levels, confirming previous findings that CC16 levels are associated with ARDS mortality.

Funder

ACCP Foundation

Foundation for the National Institutes of Health

Publisher

SAGE Publications

Subject

Biochemistry (medical),Pharmacology,Molecular Medicine

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