Use of an IL-6 assay for predicting the development of post-trauma complications

• US 5,882,872 A
• Filed: 06/10/1997
• Issued: 03/16/1999
• Est. Priority Date: 04/28/1994
• Status: Expired due to Fees

• Current Assignee: Kenneth A. Kudsk
• Original Assignee: Kenneth A. Kudsk
• Inventors: Kudsk, Kenneth A.
• Primary Examiner(s): SAUNDERS, DAVID A
• Application Number:
  US08/872,339
• Time in Patent Office: 644 Days
• Field of Search: 435/6, 435/7.21, 435/7.24, 435/7.92, 435/7.94, 435/7.32, 436/86, 436/518, 436/811
• US Class Current: 435/7.21
• CPC Class Codes: G01N 33/6869 Interleukin
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function

Abstract

Diagnostic methods are described for using the concentration of a cytokine present in serum or other biological fluids in order to predict the predisposition of an individual to post-trauma infectious and or inflammatory complications. Also described are diagnostic kits that are particularly suitable for use in such diagnosis.

Claims

1. A method for determining the predisposition of an individual subjected to a non-sterile, gross penetrating trauma to a complication of trauma prior to the onset of overt clinical symptoms of such complication, which comprises determining the concentration of the cytokine Interleukin-6 present in a biological fluid of said individual about one day post-trauma, wherein said method comprises the steps:

(A) determining the concentration of Interleukin-6 in the biological fluid of said individual subjected to said trauma; and

(B) correlating said determined serum concentration with the mechanism of injury (MI) of said trauma, the Injury Severity Score (ISS) of the severity of said trauma, or the Abdominal Trauma Index (ATI) of said trauma to thereby determine said individual'"'"'s predisposition to complication of said trauma prior to the onset of overt clinical symptoms thereof.

2. The method of claim 1, wherein said biological fluid is selected from the group consisting of blood, plasma and serum.

3. The method of claim 1, wherein said biological fluid is selected from the group consisting of cerebrospinal fluid (CSF), peritoneal fluid, pleural fluid, and joint fluid.

4. The method of claim 1, wherein said biological fluid is urine.

5. The method of claim 1, wherein said non-sterile, gross penetrating trauma is a wound or a complex fracture.

6. The method of claim 5, wherein said wound is a gun shot wound, an insect of animal bite, a knife of a laceration.

7. The method of claim 1, wherein said complication comprises an infection.

8. The method of claim 7, wherein said infection is septicemia or bacteremia.

9. The method of claim 7, wherein said infection is pneumonia.

10. The method of claim 7, wherein said infection is an intra-abdominal abscess.

11. The method of claim 7, wherein said infection is empyema.

12. The method of claim 1, wherein said determination of said cytokine concentration is accomplished by an immunoassay.

13. The method of claim 12, wherein said immunoassay is an enzyme linked immunosorbent assay.

14. The method of claim 12, wherein said immunoassay is an open-endpoint immunoassay.

15. The method of claim 12, wherein said immunoassay is a closed endpoint immunoassay.

16. The method of claim 12, wherein said immunoassay employs a monoclonal antibody, said monoclonal antibody being capable of specific binding to said cytokine.

17. The method of claim 12, wherein said immunoassay employs a polyclonal antibody, said polyclonal antibody being capable of specific binding to said cytokine.