The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery

Completed

• Conditions: Acute Kidney Injury; Chronic Kidney Disease, Stage 3; Chronic Kidney Disease, Stage 5; Cardiac Surgery; Thoracic Aortic Surgery

• Registration Number: NCT04172103
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The investigators aimed to evaluate the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.

Detailed Description

Postoperative acute kidney injury (AKI) has been investigated as an important contributor to postoperative morbidity and mortality after cardiovascular surgery. Also, temporary worsening of renal function after aortic surgery is associated with higher long-term mortality. Although the associations between AKI and chronic kidney disease (CKD) in medical or other surgical settings were reported, only a few studies evaluated this relationship in patients undergoing cardiac surgery. More specifically, the association of the severity or duration of AKI with the risk of the development of new-onset CKD after cardiac surgery has not been clearly elucidated.

It would be important to find predictors of the long-term renal function or risk factors for the development of CKD after cardiac surgery because postoperative management of high-risk patients to develop long-term renal dysfunction may prevent further deterioration in renal function and improve patient prognosis.

The investigators aimed to evaluate (1) the long-term renal function after cardiac surgery and (2) the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.

Study Timeline

• Study Start: 2019-11-19
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2009

Inclusion Criteria

• Adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017

Exclusion Criteria

• Those with off-pump coronary artery bypass
• Missing baseline serum creatinine
• Missing postoperative serum creatinine values of more than three among seven postoperative days
• Preoperative baseline chronic kidney disease with estimated glomerular filtration rate <60 ml/min/1.73m2

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
new-onset chronic kidney disease stage 3 or higher or mortality	during 3 years after surgery	development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 3 years after surgery. The new-onset chronic kidney disease was defined by at least two estimated Glomerular Filtration Rate values \<60 ml/min/1.73 m2 separated by an interval of at least three months.

Secondary Outcome Measures

Name	Time	Method
Length of postoperative hospital stay	during one month after surgery	Length of postoperative hospital stay
Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2	at three years after surgery	Incidence of estimated Glomerular Filtration Rate \<60 mL/min/1.73m2
intra-aortic balloon pulsation insertion	during surgery and postoperative one week	intra-aortic balloon pulsation insertion
Reopen for surgical bleeding	during one month after surgery	Reopen for surgical bleeding
Respiratory complication	during one month after surgery	a composite outcome including postoperative atelectasis, pneumonia, pulmonary edema, pleural effusion and pneumothorax
in-hospital mortality	during one month after surgery	all-cause mortality during hospital stay
Dependence on the regular hemodialysis	at three years after surgery	Dependence on the regular hemodialysis
new-onset chronic kidney disease stage 3 or higher or mortality	during 2 years after surgery	development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 2 years after surgery
Length of postoperative intensive care unit stay	during one month after surgery	Length of postoperative intensive care unit stay
estimated Glomerular Filtration Rate	at three years after surgery	estimated Glomerular Filtration Rate

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of