Claims for Patent: 11,096,983

Summary for Patent: 11,096,983

Title:	Angiotensin II alone or in combination for the treatment of hypotension
Abstract:	The present invention relates, inter alia, to a method comprising administering to a subject having high output shock and undergoing treatment with a catecholamine at a dose equivalent to at least about 0.2 mcg/kg/min of norepinephrine a dose of angiotensin II which is effective to raise the blood pressure of the subject to a mean arterial pressure (MAP) of about 6.5 mm Hg or above, and which is effective to reduce the dose of the catecholamine required to maintain a MAP of about 65 mm Hg to the equivalent of about 0.05-0.2 mcg/kg/min norepinephrine or less, or to the equivalent of about 0.05 mcg/kg/min norepinephrine or less.
Inventor(s):	Chawla; Lakhmir S. (McLean, VA)
Assignee:	The George Washington University a Congressionally Chartered Not-for-Profit Corporation (Washington, DC)
Application Number:	16/382,850
Patent Claims:	1. A method of treating a human subject having distributive shock, comprising administering human Angiotensin II to the human subject at an initial rate of about 20 ng/kg/min and titrating the rate down to a rate sufficient to achieve or maintain a mean arterial pressure of greater than or equal to about 65 mmHg, wherein the Angiotensin II is in the form of a salt. 2. The method of claim 1, wherein the rate is titrated down one or more times by about 1.25 ng/kg/min to about 15 ng/kg/min. 3. The method of claim 1, wherein the rate is titrated down to about 1.25 ng/kg/min to less than 20 ng/kg/min over one or more titrations. 4. The method of claim 1, wherein the Angiotensin II is administered to the human subject over a period of about 0.25 hours to about 120 hours. 5. The method of claim 1, wherein the Angiotensin II is administered to the human subject over a period of about 1 hour to about 7 hours. 6. The method of claim 1, wherein the Angiotensin II is in the form of an acetate salt. 7. The method of claim 1, wherein the Angiotensin II is administered in a parenteral composition comprising aqueous sodium chloride. 8. The method of claim 7, wherein the Angiotensin II is administered in a parenteral composition comprising sodium hydroxide. 9. The method of claim 8, wherein the Angiotensin II is administered in a parenteral composition comprising hydrochloric acid. 10. The method of claim 9, wherein the Angiotensin II is administered in a parenteral composition having a pH of from about 3.0 to about 9.0. 11. The method of claim 1, wherein the Angiotensin II is administered in a parenteral composition having a pH of about 5.5. 12. The method of claim 1, wherein the Angiotensin II is administered to the human subject at a rate sufficient to achieve a mean arterial pressure of greater than or equal to about 80 mmHg. 13. The method of claim 1, wherein the Angiotensin II is administered to the human subject at a rate sufficient to maintain a mean arterial pressure of greater than or equal to about 65 mmHg. 14. The method of claim 13, wherein the mean arterial pressure is maintained at greater than or equal to about 65 mmHg for up to about 6 hours. 15. The method of claim 13, wherein the mean arterial pressure is maintained at greater than or equal to about 65 mmHg for about 6 hours or more. 16. The method of claim 1, wherein the Angiotensin II is administered to the human subject at a rate sufficient to maintain a mean arterial pressure of greater than or equal to about 80 mmHg. 17. The method of claim 16, wherein the mean arterial pressure is maintained at greater than or equal to about 80 mmHg for up to about 6 hours. 18. The method of claim 16, wherein the mean arterial pressure is maintained at greater than or equal to about 80 mmHg for about 6 hours or more. 19. The method of claim 1, wherein the human subject is undergoing treatment with one or more vasopressors. 20. The method of claim 19, wherein the one or more vasopressors is selected from the group consisting of norepinephrine, vasopressin, phenylephrine, epinephrine, and dopamine. 21. The method of claim 19, wherein the one or more vasopressors is norepinephrine or vasopressin. 22. The method of claim 1, wherein the human angiotensin II is synthetic human angiotensin II. 23. The method of claim 1, wherein the human angiotensin II consists of the sequence of SEQ ID NO. 1. 24. A method of treating a human subject having septic shock, comprising administering human Angiotensin II to the human subject at an initial rate of about 20 ng/kg/min and titrating the rate down to a rate sufficient to achieve or maintain a mean arterial pressure of greater than or equal to about 65 mmHg, wherein the Angiotensin II is in the form of a salt. 25. The method of claim 24, wherein the human angiotensin II is synthetic human angiotensin II. 26. The method of claim 24, wherein the human angiotensin II consists of the sequence of SEQ ID NO. 1. 27. A method of treating a human subject having septic shock or distributive shock, comprising (a) administering synthetic human Angiotensin II (SEQ ID NO. 1) to the human subject at an initial rate of about 20 ng/kg/min; and (b) titrating the rate down to a rate sufficient to achieve or maintain a target mean arterial pressure of greater than or equal to about 65 mmHg; wherein the Angiotensin II is in the form of an acetate salt, and wherein the Angiotensin II is administered in a parenteral composition comprising aqueous sodium chloride, sodium hydroxide, and hydrochloric acid, and wherein the parenteral composition has a pH of about 5.5.