Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06581289

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cardiac Anaesthesia Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. MAKE 30 (Major adverse kidney event within 30 days)

    Time frame: within 30 days after surgery

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

  2. MAKE 90 (Major Adverse kidney event within 90 days)

    Time frame: within 90 days after surgery

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

  3. incidence of CKD (chronic kidney disease) within 1 year

    Time frame: 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)

  4. 1 year mortality

    Time frame: within 1 year after surgery

    death due to any cause within 1 year

  5. in-hospital mortality

    Time frame: from day of hospitalization for surgery until discharge after surgery 1year

    death which occurs during the hospitalization

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Sep 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.