Urinary PO2 predicts the development of AKI

JRCT ID: jRCTs052220198

Registered date:17/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: heart disease
• Date of first enrollment: 05/08/2023
• Target sample size: 55
• Study type: Observational

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Iguchi Naoya
• Source(s) of Monetary Support: Japan Society for the Promotion of Science