Cardiac Anesthesia Registry Including Biosignal Database for Prognostication of Postoperative Renal Outcome

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-90
SponsorYonsei University

About this trial

AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. Collecting perioperative biosignal data and studying their association with renal outcomes can help improve kidney injury, mortality, and morbidity in cardiac surgical patients. Furthermore, the occurrence of AKI, length of hospital stay, and recovery of renal function after discharge are closely associated with the development of chronic kidney disease (CKD). Therefore, regular monitoring of renal function and related indicators in cardiac surgical patients can help improve long-term outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 19 years and older scheduled for cardiac surgery using CPB

Disqualifiers

emergency operation, the patient is foreigner or illiterate and unable to read the consent form

Trial population

Patients aged 19 year and older admitted to Severance cardiovascular hospital for cardiac surgery using CPB (Cardiopulmonary bypass).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

10,000 Participants
are grouped into 1 trial group
Group A: anesthesia for cardiovascular surgery using cardiopulmonary bypass

Trial outcomes

Primary outcomes

1

post-operative AKI incidence within 1 week after cardiac surgery with CPB

The definition of AKI refers to Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work Group. KDIGO Clinical Practice Guideline for Acute Kidney Injury.

Time frame
within first 7 days after surgery

Secondary outcomes

1

MAKE 30 (Major adverse kidney event within 30 days)

death, starting dialysis, or decrease in eGFR of 25 % or more within 30 days after surgery

Time frame
within 30 days after surgery
2

MAKE 90 (Major Adverse kidney event within 90 days)

death, starting dialysis, or decrease in eGFR of 25 % or more within 90 days after surgery

Time frame
within 90 days after surgery
3

incidence of CKD (chronic kidney disease) within 1 year

at least one of the following criteria is met, with structural or functional abnormalities of the kidney persisting for at least 3 months within 1 year * urine albumin/creatinine ratio ≥ 30 mg/g * abnormality in urine sediment test or persistent hematuria * renal structural abnormalities found in image study * eGFR \< 60 ml/min/1.73m2 (GFR category G3a-G5)

Time frame
within 1 year after surgery
4

1 year mortality

death due to any cause within 1 year

Time frame
within 1 year after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: