- Sepsis is a major global health priority1
- 48.9 million annual sepsis cases worldwide
- 11.0 million annual deaths
- Leading cause of ICU deaths
- Early identification of sepsis is fundamental to impact morbidity and mortality2
Evaluate the use of Lactate, PCT or SeptiScore® either alone or in combination, in differentiating sepsis from infection negative systematic inflammation (INSI).
- 447 previously prospectively evaluated adult ICU patients (8 sites)5
- 3 Inclusion Criteria:
- 2 or more signs of:
- Temperature > 38C or <36C
- Heart rate > 90 beats/minute
- Tachypnea > 20 breaths/minute
- White blood cell count >12,000 cells/ mm3 or <4000 cells/mm3 or > 10% immature neutrophils
- Therapeutic antibiotic administration
- Lactate, PCT and SeptiCyte® RAPID samples obtained within 24 hours of ICU admission
- 3 physician panel retrospectively reviewed and categorized each patient as Sepsis or INSI. To be acceptable, at least 2 physicians had to agree on the same diagnosis.
- Area under the receiver operating curve (AUROC) with 95% confidence intervals via generalized linear models for each parameter alone and all combinations
- AUROC for discrimination between sepsis and infection negative-infectious systemic inflammation via paired t-test.
• 222 patients included (Sepsis 113; INSI 109)
• Patient Demographics
Erkan Hassan, Pharm.D.,FCCM* , Roy Davis, M.D. Ph.D† , Dayle Sampson, Ph.D.† , Russell Miller, III, M.D., M.P.H., FCCM‡ , on behalf of the MARS & VENUS Study Investigators *
Consultant Immunepxress, Inc. Baltimore, MD† / Immunexpress, Inc, Seattle, WA‡ / FirstHealth of the Carolinas, Pinehurst, N.C.*
1. Rudd KE, Johnson SC, Agesa KM, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: Analysis for the Global Burden of Disease Study. Lancet 2020;395:200-211.
2. Martin-Loeches I, Levy MM, Artigas A. Management of severe sepsis: Advances, challenges, and current status. Drug Design, Development and Therapy 2015;9:2079-2088.
3. Hernandez G, Ospina-Tascon GA, Damiani LP. Effect of resuscitation strategy targeting peripheral perfusion status vs serum lactate levels on 28 day mortality among patients with septic shock. The ANDROMEDA-SHOCK Randomized controlled trial. JAMA 2019;321(17):654-664.
4. Paudel R, Dogra P, Montgomery-Yates AA, et al. Procalcitonin: A promising tool or just another overhyped test? Int J Med Sci 2020;17(3):332-337.
5. Miller RR, Lopansri BK, Burke JP, et al. Validation of a host response assay, SeptiCyte® LAB, for discriminating sepsis from systemic inflammatory response syndrome in the ICU. Am J Respir Crit Care Med 2018;198(7):903-913.
The investigator partners, clinical study coordinators, laboratory technical staff and participants in the VENUS/VENUS supplement clinical trials