Resuscitation from shock

• US 6,682,481 B2
• Filed: 06/07/2002
• Issued: 01/27/2004
• Est. Priority Date: 06/07/2002
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Board of Regents of the University of Texas System (University of Texas System)
• Inventors: Sailors, R. Matthew, McKinley, Bruce A., Moore, Frederick A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Sweet, Thomas J
• Application Number:
  US10/165,184
• Publication Number:
  US 20030226568A1
• Time in Patent Office: 599 Days
• Field of Search: 600/301, 128/898, 604/507
• US Class Current: 600/301
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2230/202 partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 70/60 relating to pathologies

Abstract

Methods, software, and apparatuses are described for resuscitation of shock due to trauma and/or hemorrhage. A representative embodiment involves a method of treating shock in a patient. A plurality of data elements representative of a condition of the patient are acquired, and shock in the patient is treated by following a step-by-step goal directed, data driven protocol, which references the plurality of data elements. The fixed protocol may be implemented in software or otherwise.

Claims

1. A method of treating shock due to trauma or hemorrhage in a patient, comprising:

acquiring a plurality of data elements representative of a condition of the patient;

generating a step-by-step fixed protocol specific to the patient in accordance with the plurality of data elements; and

treating the shock in the patient by following the step-by-step fixed protocol, the fixed protocol referencing the plurality of data elements and being calibrated to the patient.

2. The method of claim 1, the fixed protocol being a protocol automated using logic executed iteratively by computer or other machine.

3. A computer readable medium comprising computer-executable instructions for implementing the method of claim 1.

4. A method for resuscitating a victim of shock, comprising:

identifying a risk of major organ failure;

determining indices of peripheral perfusion deficit of the victim;

determining an oxygen delivery index of the victim;

comparing the oxygen delivery index of the victim to an oxygen delivery index goal;

if the oxygen delivery index of the victim is greater than or equal to the oxygen delivery index goal;

comparing the indices of peripheral perfusion deficit with peripheral perfusion deficit thresholds; and

ending resuscitation if the indices of peripheral perfusion deficit meet the peripheral perfusion deficit thresholds; and

if the oxygen delivery index of the victim is less than the oxygen delivery index goal;

comparing hemoglobin concentration of the victim with a hemoglobin concentration threshold;

transfusing one or more units of packed red blood cells if the hemoglobin concentration of the victim is less than the hemoglobin concentration threshold;

comparing pulmonary artery wedge pressure of the victim with a pulmonary artery wedge pressure threshold;

administering a volume loading protocol if the pulmonary artery wedge pressure of the victim is less than the pulmonary artery wedge pressure threshold;

monitoring responses of the pulmonary artery wedge pressure and cardiac index of the victim to determine if the pulmonary artery wedge pressure and cardiac index are optimized; and

administering a Starling Challenge if the pulmonary artery wedge pressure and cardiac index are not optimized.

5. The method of claim 4, the identifying a risk of multiple organ failure comprising:

identifying one or more injuries;

identifying a need for at least 6 units of packed red blood cells; and

identifying an arterial base deficit of at least 6 mEq/L.

6. The method of claim 5, the identifying an injury comprising identifying an injury of the liver, spleen, mesentery, hollow viscus, kidney, pancreas, major vascular, rib, long bone, and/or pelvis.

7. The method of claim 4, the identifying a risk of multiple organ failure comprising identifying the age of the victim or identifying a history of heart disease in the victim.

8. The method of claim 4, the determining indices of peripheral perfusion deficit comprising determining arterial base deficit, serum lactate concentration, gastric mucosa regional partial pressure of CO₂, and regional minus end tidal CO₂ difference.

9. The method of claim 4, the oxygen delivery index goal being between 400 and 700 ml/min/m².

10. The method of claim 9, the oxygen delivery index goal being a first value for victims younger than 65 and a second value for victims older than 65.

11. The method of claim 10, the oxygen delivery index goal being 500 ml/min/m² for victims older than 65 and 600 ml/min/m² for victims younger than 65.

12. The method of claim 4, further comprising administering one or more intervention protocols if:

the oxygen delivery index of the victim is greater than or equal to the oxygen delivery index goal; and

the indices of peripheral perfusion deficit do not meet the peripheral perfusion deficit goals.

13. The method of claim 4, the hemoglobin concentration threshold being between 7 g/dL and 12 g/dL.

14. The method of claim 13, the hemoglobin concentration threshold being a first value for victims younger than 65 and a second value for victims older than 65.

15. The method of claim 4, the pulmonary artery wedge pressure threshold being between 8 and 15 mm Hg.

16. The method of claim 15, the pulmonary artery wedge pressure threshold being a first value for victims younger than 65 and a second value for victims older than 65.

17. The method of claim 4, further comprising administering vasopressor and inotrope therapy to the victim.

18. A method for implementing a volume loading protocol for resuscitating a victim of shock, the method comprising:

administering a first volume of Ringer'"'"'s lactate bolus to the victim;

determining a change in pulmonary artery wedge pressure of the victim in response to the administering of the first volume;

administering a second volume of Ringer'"'"'s lactate bolus to the victim if the change in pulmonary artery wedge pressure is less than a first specified increment;

measuring the pulmonary artery wedge pressure of the victim;

administering a third volume of Ringer'"'"'s lactate bolus to the victim if the pulmonary artery wedge pressure of the victim is less than a second threshold.

19. The method of claim 18, the first volume equaling the second volume.

20. The method of claim 19, the first and second volumes each being 1 L.

21. The method of claim 18, the first increment being 2 mm Hg.

22. The method of claim 18, the third volume being 1 L for victims younger than 65 and 500 mL for victims older than 65.

23. The method of claim 18, the second threshold being between 8 and 15 mm Hg.

24. A computer readable medium comprising computer-executable instructions for implementing the method of claim 18.

25. A method for implementing a Starling Challenge for resuscitating a victim of shock due to trauma or hemorrhage, the method comprising:

administering a first volume of solution to the victim;

determining a change in pulmonary artery wedge pressure of the victim in response to the administering of the first volume;

administering a second volume of the solution to the victim if the change in pulmonary artery wedge pressure is less than a first specified increment;

determining a change in cardiac index of the victim in response to the administering of the solution;

if the change in pulmonary artery wedge pressure is greater than or equal to the first specified increment and less than or equal to a second specified increment;

administering a third volume of the solution to the victim if the change in cardiac index is greater than or equal to a third specified increment;

ending the protocol if the change in cardiac index remains less than the third specified increment after two consecutive administrations of a fourth volume of the solution to the victim;

if the change in pulmonary artery wedge pressure is greater than the second specified increment;

administering a fifth volume of the solution to the victim if the change in cardiac index is greater than or equal to a fourth specified increment; and

ending the protocol if the change in cardiac index remains less than the fourth specified increment after two consecutive administrations of a sixth volume of the solution to the victim.

26. The method of claim 25, the solution comprising normal saline.

27. The method of claim 25, the first, second, third, and fourth volumes being equal.

28. The method of claim 27, the first, second, third, and fourth volumes being 500 mL normal saline.

29. The method of claim 25, the fifth and sixth volumes being equal.

30. The method of claim 29, the fifth and sixth volumes being 250 mL normal saline.

31. The method of claim 25, the first specified increment being 2 mm Hg.

32. The method of claim 25, the second specified increment being 4 mm Hg.

33. The method of claim 25, the third specified increment being 0.3 L/min/m².

34. The method of claim 25, the third and fourth specified increments being 0.3 L/min/m².

35. A computer readable medium comprising computer-executable instructions for implementing the method of claim 25.

36. A method for implementing a vasopressor and inotrope therapy for resuscitating a victim of shock, the method comprising:

if mean arterial pressure of the victim is less than an arterial pressure threshold;

administering a vasopressor agent at a first rate;

determining mean arterial pressure in response to the vasopressor agent;

administering the vasopressor agent at a second rate, the second rate being greater than the first rate and less than a first maximum rate, until the mean arterial pressure meets or exceeds the arterial pressure threshold;

if mean arterial pressure of the victim is greater than or equal to the arterial pressure threshold and an oxygen delivery index of the victim is less than an oxygen delivery index goal;

administering an inotrope agent at a third rate;

determining hemodynamic performance in response to the inotrope agent;

administering the inotrope agent at a fourth rate, the fourth rate being greater than the third rate and less than a second maximum rate, until the hemodynamic performance meets a hemodynamic performance goal.

37. The method of claim 36, the arterial pressure threshold being 65 mm Hg.

38. The method of claim 36, the vasopressor agent comprising norepinephrine.

39. The method of claim 38, the first rate being 0.05 mcg/kg/min.

40. The method of claim 39, the second rate being one or more increments of 0.05 mcg/kg/min greater than the first rate.

41. The method of claim 40, the first maximum rate being 0.2 mcg/kg/min.

42. The method of claim 36, the inotrope agent comprising milrinone or dobutamine.

43. The method of claim 42, the third rate being 0.3 mcg/kg/min for milrinone and 2.5 mcg/kg/min for dobutamine.

44. The method of claim 43, the fourth rate being one or more increments of 0.1 mcg/kg/min for milrinone and 2.5 mcg/kg/min for dobutamine.

45. The method of claim 44, the second maximum rate being 0.8 mcg/kg/min for milrinone and 20 mcg/kg/min for dobutamine.

46. The method of claim 36, the hemodynamic performance comprising hemoglobin concentration, cardiac index, or oxygen delivery index.

47. A computer readable medium comprising computer-executable instructions for implementing the method of claim 36.