heart disease Valvular disease, Ischemic heart disease,
Conditions
Interventions
None listed
Sponsors
Iura Akira
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18 years or older at the time of obtaining consent 2) Scheduled cardiac surgery requiring cardiopulmonary bypass with aortic cross clamp (valve replacement/repair, coronary artery bypass grafting or both combined) 3) A written consent of this study was obtained
Exclusion criteria
Exclusion criteria: 1) Patients have no indications of urinary catheters insertion 2) Patients with prostatic hyperplasia 3) Patients with urinary tract infection 4) Patients are undergoing surgery including aortaor requiring hypothermic circulatory arrest procedure 5) Patientson hemodialysis 6) Patients on mechanical circulation support 7) Patients who are pregnant or possibly pregnant 8) Patients who are deemed inappropriate as research subjects by the investigators for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Area under the ROC curve of candidate indicator for development of AKI 2)Sensitivity of candidate indicator for development of AKI 3)Specificity of candidate indicator for development of AKI 4)Accuracy of candidate indicator for development of AKI | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The difference between area under the ROC curve of the best candidate indicator for development of AKI and urinary NGAL/ urinary creatinine ratios 2)The difference between area under the ROC curve of the best candidate indicator for development of AKI and urinary NGAL 3)Area under the ROC curve of the best candidate indicator for development of AKI in subgroups 4)Sensitivity of the best candidate indicator for development of AKI in subgroups 5)Specificity of the best candidate indicator for development of AKI in subgroups 6)Accuracy of the best candidate indicator for development of AKI in subgroups 7)Interval average of measurement of intraoperative UPO2 and hemodynamic parameters 8)Interval average of percentage change of intraoperative UPO2 and hemodynamic parameters 9)The worst value of intraoperative UPO2 and hemodynamic parameters on each interval 10)Regression coefficient of UPO2 related factors on multiple regression model to the best candidate indicator for development of AKI Safety evaluation 1)Development of hematuria, urinary tract infection and urinary tract injury 2)Other adverse event 3)Device issue | — |
Contacts
Public ContactAkira Iura
The University of Osaka Hospital
Outcome results
None listed