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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury; Cardiac Surgery; Chronic Kidney Disease, Stage 5; Chronic Kidney Disease, Stage 3; 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 Type: Observational
• Enrollment (Actual): 2009

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A retrospective cohort of the adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Length of postoperative hospital stay	Length of postoperative hospital stay	during one month after surgery
Length of postoperative intensive care unit stay	Length of postoperative intensive care unit stay	during one month after surgery
intra-aortic balloon pulsation insertion	intra-aortic balloon pulsation insertion	during surgery and postoperative one week
Reopen for surgical bleeding	Reopen for surgical bleeding	during one month after surgery
Respiratory complication	a composite outcome including postoperative atelectasis, pneumonia, pulmonary edema, pleural effusion and pneumothorax	during one month after surgery
in-hospital mortality	all-cause mortality during hospital stay	during one month after surgery
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
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
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
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
Dependence on the regular hemodialysis	Dependence on the regular hemodialysis	at three years after surgery
estimated Glomerular Filtration Rate	estimated Glomerular Filtration Rate	at three months after surgery
estimated Glomerular Filtration Rate	estimated Glomerular Filtration Rate	at one year after surgery
estimated Glomerular Filtration Rate	estimated Glomerular Filtration Rate	at two years after surgery
estimated Glomerular Filtration Rate	estimated Glomerular Filtration Rate	at three years after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Won Ho Kim, MD, PhD, Associate Professor

Publications and helpful links

General Publications

• 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.
• 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. No abstract available.

Helpful Links

• Statistical analysis plan

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; chronic kidney disease; acute kidney injury; thoracic aortic surgery
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 1909-115-1066

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