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

Acute Kidney Injury Clinical Trial

Official title:

The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery: a Retrospective Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172103
• Other study ID #: 1909-115-1066
• Status: Completed
• Start date: November 19, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2009
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Surgery
• Chronic Kidney Disease, Stage 3
• Chronic Kidney Disease, Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic
• Thoracic Aortic Surgery
• Wounds and Injuries

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Chawla LS, Eggers PW, Star RA, Kimmel PL. Acute kidney injury and chronic kidney disease as interconnected syndromes. N Engl J Med. 2014 Jul 3;371(1):58-66. doi: 10.1056/NEJMra1214243. Review. — View Citation

Wang Y, Bellomo R. Cardiac surgery-associated acute kidney injury: risk factors, pathophysiology and treatment. Nat Rev Nephrol. 2017 Nov;13(11):697-711. doi: 10.1038/nrneph.2017.119. Epub 2017 Sep 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new-onset chronic kidney disease stage 3 or higher or mortality	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.	during 3 years after surgery
Secondary	new-onset chronic kidney disease stage 3 or higher or mortality	development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 1 year after surgery	during 1 year after surgery
Secondary	new-onset chronic kidney disease stage 3 or higher or mortality	development of new-onset chronic kidney disease stage 3 or higher or all-cause mortality developed during 2 years after surgery	during 2 years after surgery
Secondary	Length of postoperative hospital stay	Length of postoperative hospital stay	during one month after surgery
Secondary	Length of postoperative intensive care unit stay	Length of postoperative intensive care unit stay	during one month after surgery
Secondary	intra-aortic balloon pulsation insertion	intra-aortic balloon pulsation insertion	during surgery and postoperative one week
Secondary	Reopen for surgical bleeding	Reopen for surgical bleeding	during one month after surgery
Secondary	Respiratory complication	a composite outcome including postoperative atelectasis, pneumonia, pulmonary edema, pleural effusion and pneumothorax	during one month after surgery
Secondary	in-hospital mortality	all-cause mortality during hospital stay	during one month after surgery
Secondary	Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2	Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2	at three months after surgery
Secondary	Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2	Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2	at one year after surgery
Secondary	Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2	Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2	at two years after surgery
Secondary	Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2	Incidence of estimated Glomerular Filtration Rate <60 mL/min/1.73m2	at three years after surgery
Secondary	Dependence on the regular hemodialysis	Dependence on the regular hemodialysis	at three years after surgery
Secondary	estimated Glomerular Filtration Rate	estimated Glomerular Filtration Rate	at three months after surgery
Secondary	estimated Glomerular Filtration Rate	estimated Glomerular Filtration Rate	at one year after surgery
Secondary	estimated Glomerular Filtration Rate	estimated Glomerular Filtration Rate	at two years after surgery
Secondary	estimated Glomerular Filtration Rate	estimated Glomerular Filtration Rate	at three years after surgery

External Links

•   Statistical analysis plan