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OwnerMichelle Chew, Henrik Andersson +1inventors
InventorsMichelle Chew, Henrik Andersson, Darius Wilson
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The invention relates to a method for the diagnosis, prognosis, risk assessment and/or risk stratification of an adverse event in the health of a postsurgical patient, comprising providing at least one sample of a patient, who has undergone, is undergoing or will undergo surgery, wherein the at least one sample has been isolated from the patient presurgically, perioperative or postsurgically, determining a level of at least one biomarker selected from the group consisting of proADM, PCT and pro ET-1 or fragment(s) thereof in said at least one sample, wherein said level of the at least one biomarker or fragment(s) thereof correlates with the likelihood of said adverse event. In some embodiments the method is used for predicting or diagnosing an elevated or decreased likelihood of a postsurgical infection or blood infection. In some embodiments the method is used for predicting or diagnosing an elevated or decreased likelihood of a postsurgical adverse cardiovascular or cerebrovascular event, preferably a major adverse cardiovascular or cerebrovascular event (MACCE), major myocardial injury after non-cardiac surgery (MINS) or perioperative myocardial injury (PMI). In some embodiments the method additionally comprises therapy guidance, stratification and/or control in relation to said postsurgical adverse events, in particular an infection or an adverse cardiovascular or cerebrovascular event.
Method for the diagnosis, prognosis, risk assessment and/or risk stratification of an adverse event in the health of a postsurgical patient, comprising
Method according to any one of the preceding claims, wherein the adverse event is a blood stream infection, sepsis, severe sepsis and/or septic shock.
Method according to any one of the preceding claims, wherein a first sample is isolated from the patient at a first time point and a second sample is isolated from the patient at a second time point, wherein preferably between the first and the second time point at least 6 hours, 12 hours, 24 hours, 36 hours, 48 hours or more have passed.
Method according to any one of the preceding claims, a first sample is isolated from the patient at a first time point and a second sample is isolated from the patient at a second time point, wherein the likelihood of an adverse event correlates with the absolute difference, the ratio and/or the rate of change of the level of said biomarker in regards to the first and second time point.
Method according to any one of the preceding claims, wherein a first sample is isolated from the patient postsurgically at a first time point and a second sample is isolated from the patient postsurgically at a second time point, wherein preferably between the first and second time point at least 12 hours, 24 hours, 36 hours, 48 hours or more have passed and an increase or a leveling in the level of proADM or fragment(s) thereof indicates an elevated likelihood of the adverse event.
Method according to any one of the preceding claims, wherein determining a level of proADM or fragment(s) thereof comprises determining a level of MR-proADM or mature ADM in the sample.
Method according to any one of the preceding claims, additionally comprising a therapy guidance, stratification and/or control.
Method according to any one of the preceding claims, wherein the level of the at least one biomarker correlates with the likelihood of an infection that is indicative of initiation of a treatment with an anti-infective agent, preferably an antibiotic agent.
Method according to any one of the preceding claims, wherein the level of the at least one biomarker correlates with the likelihood of a postsurgical adverse event that is indicative of the patient requiring frequent or increased level of monitoring and/or critical care.
Method according to any one of the preceding claims, wherein determining a level of at least one biomarker comprises determining the level of proADM or fragment(s) thereof and a level of proADM or fragment(s) thereof above a threshold value indicates an elevated likelihood of an infection.
Method according to any one of the preceding claims, wherein determining a level of at least one biomarker comprises determining the level of proADM or fragment(s) thereof and a level of proADM or fragment(s) thereof above a threshold value indicates an elevated likelihood of a blood infection.
Method according to any one of the preceding claims, wherein determining a level of at least one biomarker comprises determining the level of proADM or fragment(s) thereof and a level of proADM or fragment(s) thereof above a threshold value indicates an elevated likelihood of an infection, preferably a blood infection, and an adverse cardiovascular or cerebrovascular event, preferably a MACCE, PMI and/or a MINS.
Kit for carrying out the method according to any one of the preceding claims, wherein the kit comprises
Method for the diagnosis, prognosis, risk assessment and/or risk stratification of an adverse event in the health of a postsurgical patient, comprising
Method for the diagnosis, prognosis, risk assessment and/or risk stratification of an adverse event in the health of a postsurgical patient, comprising
Method according to any one of the preceding claims, wherein the patient has undergone, is undergoing or will undergo a non-cardiac surgery.
Method according to any one of the preceding claims, wherein the patient has undergone, is undergoing or will undergo an abdominal surgery.
Method according to any one of the preceding claims, wherein the patient is 50 years or older.
Method according to any one of the preceding claims, wherein the sample is isolated presurgically within 7 days, preferably within 3 days, one day, 12 hours or less before the surgery.
Method according to any one of the preceding claims, wherein the sample is isolated from the patients postsurgically at least 12 hours, 24 hours, 48 hours, 72 hours or more after surgery, and/or within 72 hours, 48 hours, 24 hours, 12 hours or less after the surgery.
Method according to any one of the preceding claims, wherein the sample is isolated postsurgically within 12 hours, preferably within 6 hours after surgery.
Method according to any one of the preceding claims, wherein the sample is isolated one day after surgery.
Method according to any one of the preceding claims, wherein the sample is isolated two days after surgery.
Method according to any one of the preceding claims, wherein the sample is isolated three days after surgery.
Method according to any one of the preceding claims, wherein a first sample is isolated presurgically and/or perioperatively and a second sample is isolated postsurgically.
Method according to any one of the preceding claims, wherein a first sample is isolated presurgically and a second sample is isolated perioperatively and/or postsurgically.
Method according to any one of the preceding claims, wherein the sample is selected from the group consisting of a blood sample, such as a whole blood sample, a serum sample or a plasma sample, a saliva sample and/or a urine sample.
Dependencies are inferred from the claim text.