GDF-15 and/or Troponin T for Predicting Kidney Failure in Heart Surgery Patients

Abstract

The present disclosure relates to the field of laboratory diagnostics. Specifically, means and methods are disclosed for determining a patient's risk of suffering from acute kidney injury after a surgical procedure based on the detection of GDF-15, troponin T and/or a natriuretic peptide.

1 . A method for determining a patient's risk of developing acute kidney injury (AKI) during or after a surgical procedure, the method comprising the steps of:
 (a) determining the amount of a biomarker in a blood, plasma, or serum sample from the patient which has been taken before the patient undergoes the surgical procedure, wherein the biomarker comprises GDF-15 and/or Troponin;   (b) comparing the determined amount of the biomarker with a reference amount, wherein the patient's risk of developing AKI during or after the surgical procedure is predicted.   
     
     
         2 . The method of  claim 1 , wherein the method further comprises the steps of:
 (a) determining the amount of NTproBNP in a blood, plasma, or serum sample from the patient which has been taken before the patient undergoes the surgical procedure,   (b) comparing the determined amount of the biomarker and NTproBNP with a reference amount, wherein the patient's risk of developing AKI during or after the surgical procedure is predicted.   
     
     
         3 . The method of  claim 1 , wherein the Troponin is Troponin T. 
     
     
         4 . The method of  claim 1 , further comprising:
 determining the patient is at-risk of developing AKI during or after the surgical procedure if the amount of biomarker in the sample is greater than the biomarker reference amount.   
     
     
         5 . The method of  claim 1 , wherein the determining step comprises:
 (a) contacting, in vitro, a portion of a blood, plasma, or serum sample obtained from the patient prior to the surgical procedure with a first antibody comprising a label,   and a second antibody comprising a label that is capable of emitting a detectable signal,   wherein each antibody has specific binding affinity for the biomarker, thereby forming a complex between the antibodies and the biomarker;   (b) contacting the complex with a ligand capable of specifically binding the label of the first antibody, thereby forming a complex between the ligand, antibodies, and biomarker;   (c) contacting the complex with a solid support capable of binding the ligand, thereby capturing the complex on the solid support;   (d) inducing the emission of the detectable signal from the label of the second antibody;   (e) measuring the detectable signal, and   (f) calculating the amount of biomarker in the sample, the signal being proportional to the amount of biomarker in the sample, whereby the amount of biomarker in the sample is determined.   
     
     
         6 . The method of  claim 1 , further comprising:
 (c) comparing the determined amount of the biomarker with a second reference amount, and determining the patient is at-risk of developing AKI requiring hemodialysis during or after the surgical procedure if the amount of biomarker in the sample is greater than the second reference amount.   
     
     
         7 . The method of  claim 4 , further comprising:
 deciding whether the at-risk patient will undergo the surgical procedure based on the specific needs and risks of the patient.   
     
     
         8 . The method of  claim 7 , further comprising:
 implementing a protective treatment plan for the at-risk patient by controlling or avoiding known risk factors that precipitate AKI before, during, and/or after the surgical procedure if it is performed.   
     
     
         9 . The method of  claim 1 , wherein the surgical procedure is orthopedic surgery, a tumor resection, surgery of the gastrointestinal tract not involving tumor resection, or cardiac surgery. 
     
     
         10 . A method for deciding whether a risk patient is eligible for a surgical procedure comprising the steps of:
 (a) determining the amount of GDF-15 and/or troponin in a sample of the patient;   (b) comparing the determined amount with a reference amount, whereby it is decided whether the patient is eligible for the surgical procedure.   
     
     
         11 . A method for predicting in a risk patient having been subjected to a surgical procedure the risk to suffer from acute kidney injury comprising the steps of:
 (a) determining the amount of GDF-15 in a sample of the patient;   (b) comparing the determined amount with a reference amount, whereby the risk of the patient to suffer from acute kidney injury is predicted.   
     
     
         12 . A device for predicting a patient's risk of developing acute kidney injury (AKI) during or after a surgical procedure, comprising:
 (a) an analyzing unit comprising means for determining the amount of a biomarker in a blood, plasma, or serum sample from the patient which has been taken before the patient undergoes the surgical procedure, wherein the biomarker comprises GDF-15 and/or Troponin; and   (b) an evaluation unit comprising a computer for comparing the determined amount of biomarker with a reference amount, predicting the patient's risk of AKI during or after the surgical procedure, and providing an output indicating the risk of AKI.   
     
     
         13 . The device of  claim 12 , wherein the biomarker further comprises GDF-15, Troponin, and/or NTproBNP. 
     
     
         14 . The device of  claim 12 , wherein the analyzing unit comprises a means for:
 (a) contacting, in vitro, a portion of a blood, plasma, or serum sample obtained from the patient prior to the surgical procedure with a first antibody comprising a label,   and a second antibody comprising a label that is capable of emitting a detectable signal,   wherein each antibody has specific binding affinity for the biomarker, thereby forming a complex between the antibodies and the biomarker;   (b) contacting the complex with a ligand capable of specifically binding the label of the first antibody, thereby forming a complex between the ligand, antibodies, and biomarker;   (c) contacting the complex with a solid support capable of binding the ligand, thereby capturing the complex on the solid support;   (d) inducing the emission of the detectable signal from the label of the second antibody;   (e) measuring the detectable signal, and   (f) calculating the amount of biomarker in the sample, the signal being proportional to the amount of biomarker in the sample, whereby the amount of biomarker in the sample is determined.