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

NCT06581289 | Not Yet Recruiting

• 1 other identifier: 4-2024-0557
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Anaesthesia

Keywords

Acute Kidney Injury; Cardiovascular Surgical Procedures; Cardiopulmonary Bypass; Biomarker; Biosignal data; Renal outcome

Outcome Measures

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.

  within first 7 days after surgery

Secondary Outcomes (5)

• MAKE 30 (Major adverse kidney event within 30 days)

  within 30 days after surgery

• MAKE 90 (Major Adverse kidney event within 90 days)

  within 90 days after surgery

• incidence of CKD (chronic kidney disease) within 1 year

  within 1 year after surgery

• 1 year mortality

  within 1 year after surgery

• in-hospital mortality

  from day of hospitalization for surgery until discharge after surgery 1year

Study Arms (1)

anesthesia for cardiovascular surgery using cardiopulmonary bypass

patients scheduled for cardiovascular surgery with CPB which requires anesthesia in the operating room

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: September 3, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2034
• Study Completion (Estimated): September 30, 2034
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)