Advanced detection of sepsis

• US 9,091,698 B2
• Filed: 03/10/2014
• Issued: 07/28/2015
• Est. Priority Date: 04/03/2008
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Shi, Song, Moore, Richard L., Garrett, James
• Primary Examiner(s): COOK, LISA V
• Application Number:
  US14/203,367
• Publication Number:
  US 20140302533A1
• Time in Patent Office: 505 Days
• US Class Current: 1/1
• CPC Class Codes: C12Q 1/6881 for tissue or cell typing, e.g. human leukocyte antigen [HLA] probes
• CPC Class Codes: C12Q 2600/158 Expression markers
• CPC Class Codes: G01N 2333/90209 acting on NADH or NADPH (1.6), e.g. those with a heme protein as acceptor (1.6.2) (general), Cytochrome-b5 reductase (1.6.2.2) or NADPH-cytochrome P450 reductase (1.6.2.4)
• CPC Class Codes: G01N 2333/91051 Acyltransferases other than aminoacyltransferases (general) (2.3.1)
• CPC Class Codes: G01N 2800/26 Infectious diseases, e.g. generalised sepsis
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
• CPC Class Codes: G01N 33/92 involving lipids, e.g. cholesterol , lipoproteins, or their receptors steroid hormones G01N33/743

Abstract

The present invention relates to methods, monitors and systems, useful, for example, for advanced detection of sepsis in a subject.

Claims

1. A method for the advanced detection of sepsis in a SIRS-positive subject, comprising the steps of:

(a) measuring at a plurality of time points, prior to laboratory confirmation of a clinically significant infection causative of sepsis, an amount of procalcitonin in fluid or tissue of the subject; and

(b) measuring at a plurality of time points, prior to laboratory confirmation of a clinically significant infection causative of sepsis, one or more clinical markers of the subject, to detect sepsis in the subject;

wherein an increase in the amount of procalcitonin from a previous amount over a 24 hour interval detects sepsis in the subject.

2. The method of claim 1, wherein the one or more clinical marker(s) are selected from the group consisting of respiratory rate, body temperature, heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, white blood cell count, monocyte count, lymphocyte count, granulocyte count, neutrophil count, immature neutrophil to total neutrophil ratio, platelet count, serum creatinine concentration, urea concentration, lactate concentration, glucose concentration, base excess, pO₁ and HCO₃⁻

concentration.

3. The method of claim 2, wherein one clinical marker is measured.

4. The method of claim 3, wherein respiratory rate is measured.

5. The method of claim 2, wherein two or more clinical markers are measured.

6. The method of claim 5, wherein respiratory rate and body temperature are measured.

7. The method of claim 1, wherein the advanced detection is at least 12 hours prior to the onset of sepsis.

8. The method of claim 2, wherein a body temperature greater than 38°

C. detects sepsis.

9. The method of claim 2, wherein a body temperature less than 36°

C. detects sepsis.

10. The method of claim 2, wherein a respiratory rate greater than 20 breaths per minute detects sepsis.

11. The method of claim 1, wherein the amount is measured by spectrometry, chromatography, immunoassay, electrophoresis or enzymatic assay.

12. The method of claim 1, wherein the fluid or tissue is blood, plasma, saliva, serum, sputum, urine, cells, cellular extract or tissue biopsy.