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

Not yet recruiting

• Conditions: Cardiac Anaesthesia

• Registration Number: NCT06581289
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-27
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-29
• Last Update Submitted: 2024-08-29
• Study Start: 2024-09
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2034-08-01
• Study Completion: 2034-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Aged 19 years and older scheduled for cardiac surgery using CPB

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
post-operative AKI incidence within 1 week after cardiac surgery with CPB	within first 7 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
MAKE 30 (Major adverse kidney event within 30 days)	within 30 days after surgery	death, starting dialysis, or decrease in eGFR of 25 % or more within 30 days after surgery
incidence of CKD (chronic kidney disease) within 1 year	within 1 year after surgery	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)
MAKE 90 (Major Adverse kidney event within 90 days)	within 90 days after surgery	death, starting dialysis, or decrease in eGFR of 25 % or more within 90 days after surgery
1 year mortality	within 1 year after surgery	death due to any cause within 1 year
in-hospital mortality	from day of hospitalization for surgery until discharge after surgery 1year	death which occurs during the hospitalization

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of