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

Cardiac Anesthesia Registry Including Biosignal Database for Prognostication of Postoperative Renal Outcome: Cardiac Anesthesia Renal Outcome in Severance Cardiovascular Hospital - DataBase (CARS-DB)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Anaesthesia

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital
    • Contact: SUNGMIN SUH, MD; Phone Number: 82-10-8916-5701; Email: suh5701@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
anesthesia for cardiovascular surgery using cardiopulmonary bypass; patients scheduled for cardiovascular surgery with CPB which requires anesthesia in the operating room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within first 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within 30 days after surgery
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	within 90 days after surgery
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)	within 1 year after surgery
1 year mortality	death due to any cause within 1 year	within 1 year after surgery
in-hospital mortality	death which occurs during the hospitalization	from day of hospitalization for surgery until discharge after surgery 1year

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): August 1, 2034
• Study Completion (Estimated): September 30, 2034

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 29, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Biomarker; Cardiopulmonary Bypass; Acute Kidney Injury; Renal outcome; Cardiovascular Surgical Procedures; Biosignal data
• Other Study ID Numbers: 4-2024-0557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No